Category COSMETIC APPLICATIONS. OF LASER AND LIGHT-. BASED SYSTEMS

I mpact on Physician Practices

The impact of aesthetic home-use devices on physician practices has been modest as of mid-2007; however, this is expected to change with the next generation of considerably more efficacious devices. First-generation home-use systems have largely provided only incremental improvements over conventional home-use aesthetic products. For example, home electrolysis units offer only marginally longer-lasting hair removal than waxing and tweezing; and other types of hair-removal devices such as electric shavers and rotating coil units are not substantially different from shaving. Therefore, these devices have posed effectively no threat to physicians offering light-based hair removal. In fact, they may have emphasized the efficacy of office-based treatments, for consumers disappointed in the results from these supposed “advancements.”

However, the next generation of home hair-removal devices, including lasers from Palomar/Gillette, Spectrageneics, and others, is expected to dramatically shift this dynamic by making substantially more efficacious treatments available to the consumer at home. Although home-use devices will never offer the results possible from professional equip­ment, they will nonetheless provide significantly greater benefit than topical and other conventional products; for some consumers, particularly those who are cost-conscious, this will be sufficient to wean them from professional treatments to home-use products.

For consumers who are more loyal to professional treatments, new home-use devices will offer a means to maintain professional results for longer periods of time and/or try a new type of procedure at home before investing in a professional procedure. A small but growing proportion of savvy physicians will market to this clientele by:

– explaining to them the benefits and limitations of new home-use devices vis-a-vis professional treatments;

– selling them complimentary topical, and other products that will boost the results delivered by home-use devices.

However, many physicians will lose business to home-use devices, particularly in the short run, as consumers try the new products. Practices that stand the most to lose include those that market mainly on the basis of price, those with suboptimal marketing programs, and those that focus on hair removal.

[1] Based on the target geometry, the size of the pigmented area (heater) d1, size of the target d2, distance between targets d3, the geometrical factor x = d2/d1 and density factor can be determined.

[2] Based on the thermal properties of the target and chromophore, the tempera­

ture of pigmented area absorption loss T1max, temperature of target damage

[4]VelaSmooth and TriActive laser systems differ only in that VelaSmooth incorporates radiofrequency into its protocol, while TriActive incorporates superficial cooling.

[5] Device trade or proprietary name, common or usual name or classification,

Class of the device (Class I, II, III)

• Submitter’s name and address, contact person, telephone number, and fax number, Representative/Consultant if applicable

[6] Domestic manufacturers introducing a finished device51 into the US market;

[7] Specification developers introducing a finished device to the US market;

[8] Treatment Trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

• Prevention Trials look for better ways to prevent a given disease in people who have never had that disease or to prevent a disease from returning. Pre­ventative approaches include medicines, vitamins, vaccines, minerals, and lifestyle changes.

• Diagnostic Trials are conducted to find better tests or procedures for diagnos­ing a particular disease or condition.

• Screening Trials test the best way to detect certain diseases or health conditions.

• Quality of Life Trials (or supportive care trials) explore ways to improve com­fort and the quality of life for individuals with a chronic illness.

• Prospective Trials—Users are identified and then followed over time.

• Randomized Trials—Users are grouped by chance into (typically) a treatment group and a control group (also called a placebo group). A control group receives either the current standard treatment or a placebo—an inactive dose or treatment. The results of the control group are then compared with those of the treatment group.

• Cross-over Trials—Users receive both the treatment and the placebo at differ­ent times, with careful monitoring of their responses to both approaches.

• Double-blinded Trials—Neither the user nor the researcher knows if the user is receiving the treatment or the placebo.

[9] Labeling—The device must be labeled in accordance with the labeling provisions of the IDE regulation91 and must bear the statement “CAUTION – Investigational Device. Limited by Federal (or United States) law to investi­gational use”.

• Distribution—Investigational devices can only be distributed to qualified investigators.92

[10] Labeling—The device must be labeled in accordance with the labeling provisions of the IDE regulation99 and must bear the statement “CAUTION – Investigational Device. Limited by Federal (or United States) law to investi­gational use.”

• IRB Approval—The sponsor must obtain and maintain IRB approval through­out the investigation as a nonsignificant risk device study;

• Informed Consent—The sponsor must assure that investigators obtain and document informed consent from each subject according to 21 CFR §50, Pro­tection of Human Subjects, unless documentation is waived by an IRB in accordance with §56.109(c);

• Monitoring—All investigations must be properly monitored to protect the human subjects and assure compliance with approved protocols;100

• Records and Reports—Sponsors are required to maintain specific records101 and make certain reports as required by the IDE regulation.

• Investigator Records and Reports—The sponsor must assure that participat­ing investigators maintain records and make reports as required (see Respon­sibilities of Investigators); and

• Prohibitions—Commercialization, promotion, test marketing, misrepresentation of an investigational device, and prolongation of the study are prohibited.102

[11] Promote or test-market an investigational device, until after FDA has approved the device for commercial distribution.

[12] The Bench data in support of efficacy and safety for laser and light-based sys­tems may include laser irradiance measurements, measurements of scattered and reflected light from the treatment area, demonstration of proper function­ing of any safety features such as skin-contact sensors, laser beam profile, uniformity of the laser irradiation on the skin surface, maximum permissible exposure (MPE) calculations for eye safety, and laser power degradation on simulated use.

Consumer Response

As of today, consumers have demonstrated a strong desire for efficacious home-use products and equally strong comfort with the technologies introduced. Far from being intimidated by words like “laser,” “radio frequency,” “microcurrent,” “chemical peel,” “microdermabrasion,” on the boxes of these new products, consumers have embraced them as a means to access treatments that were once only available through physicians. This offers the potential of greater convenience at a lower cost. As these products have generally been developed so that consumers can easily and safely use them at home, they have not yet been proven too complex or sophisticated for the average value-conscious consumer

Light BioScience

о Palomar

■ Photo Therapeutics

Radiancy

■ Spectragenics

0 Syneron

Tyrell

□ Ya-Man

ш Others

Figure 25.1 Aesthetic home device retail sales by company, 2006-2011.

to try. For aesthetic procedure patients, this confidence is also fueled in part by the rising usage by physicians of nurses, aestheticians and others to perform treatments, leading con­sumers to believe that with proper instruction, they could also operate advanced aesthetic devices.

That said, not all the emerging home-use products have provided a high cost-benefit. Some have proven relatively ineffective, or have simply not lived up to the consumers’ expectations. This has largely been the result of unbalanced marketing campaigns, wherein the benefits of new products are exaggerated to justify their higher prices, with the inevi­table consequence of consumer dissatisfaction. Among the more spectacular examples of this phenomenon has been rotating coil hair-removal systems, which were initially pro­moted as a quick and painless method of long-term hair removal. After rushing out to try the EpiLady, which launched the category, women of all ages found that this was not the case at all, and the resulting negative publicity drove the product’s distributors into bank­ruptcy. Marketers of newer home-use devices appear to be more cautious, so that accep­tance of the products is proceeding in a more controlled and sustainable manner.

Market Growth

These ongoing product development activities are expected to result in the launch of a plethora of devices, with a strong related promotion. As this occurs, the sale of home-use devices will rise by 38.3% per year on average; from an estimated $33.4 million in 2006 to $771.7 million in 2011, according to industry research firm Medical Insight. The most sustained growth will occur when Palomar and Syneron enter the market with strong mar­keting support from Gillette and Procter & Gamble, respectively. It should be noted, how­ever, that these estimates reflect the total retail dollars spent on home use aesthetic devices and not necessarily the revenues earned by manufacturers. Because retail markups can be as much as 50% or more, device sales revenues represent total dollars spent on each device which will be divided between device developers and their distribution partners.

Radiancy’s products accounted for 67.4% of all retail dollars spent on advanced home – use devices in 2006, according to Medical Insight. By 2011 Palomar and Syneron are expected to stake out more significant positions, as are other manufacturers, as shown in Fig. 25.1.

Over and above the sales of devices, consumers will also purchase disposable tips and cartridges, as they currently do for razors, since most, although not all the home-use devices will include a disposable component. This is the case, for example, with Radiancy’s No! No! As this occurs, sales of its disposables will rise by more than 31% per year from about $10 million in 2006 to $48 million in 2011, according to Medical Insight.

Next Generation Home-Use Devices

The new generation of home-use devices incorporates advanced technologies such as phototherapy, radio frequency (RF), ultrasound, and so on, and therefore requires FDA clearance to market, supported by rigorous clinical studies demonstrating the safety and efficacy in the intended application. Leading devices that meet these criteria, both available and under development, are shown in Table 25.2.

Table 25.2 Next Generation Home Aesthetic Devices

Company

Product

Name

Application

Development

Status

Expected

Launch

Palomar

n/a

Hair removal

FDA cleared

2008

Radiancy

No! No!

Hair removal

Launched

n/a

Spectragenics

i-epi

Hair removal

Launched (Japan)

2008 (US, EU)

Ya-Man

n/a

Hair removal

Launched (Asia)

2008 (US, EU)

Radiancy

CTL

Acne

Launched

n/a

Tyrell

Zeno

Acne

Launched

n/a

Palomar

n/a

Skin rejuvenation

Early development

2009

Aesthera

n/a

Skin rejuvenation

Early development

2009

Candela

n/a

Skin rejuvenation

Early development

2009

CyDen

n/a

Skin rejuvenation

Early development

2008

Light BioScience

n/a

Skin rejuvenation

FDA clearance

2008

pending

Photo

New-U

Skin rejuvenation,

FDA clearance

2008

Therapeutics

acne

pending

Radiancy

FSD

Skin rejuvenation

Launched

n/a

Syneron

n/a

Skin rejuvenation

Early development

2009

Xthetix

n/a

Skin rejuvenation

Early development

2009

Source: Medical Insight, Inc.

As of mid-2007, few of these were available. One exception to this was a set of home-use devices offered by Israel-based Radiancy. A leader in the professional aesthetic device market, Radiancy manufactures equipment that delivers Light-Heat Energy (LHE), a pro­prietary technology utilizing thermal energy (heat), as well as photothermolysis to achieve intended effects.

In the home-device market, Radiancy was an early pioneer with the introduction of its No! No! hair-removal device. First launched in 2004, the system uses a patented propri­etary technology that Radiancy calls “thermicon.” In this process, thermal energy is delivered to the hair follicle with a high-temperature thermodynamic wire that glides just above the skin and singes hair at the skin surface, while conducting thermal energy through the hair shaft down the follicle. Heat energy from the device, transiently stored in the hair shaft, completes the thermolysis process. An electromechanical system moni­tors the device’s movement over the skin and controls energy delivery; when the sensors detect that the device is being moved too slowly, heating of the wire stops, and a mechan­ical mechanism rapidly raises the heating wire away from the skin. Radiancy says that such repeated treatments weaken the hair follicle and lead to reduced hair growth. In clinical studies, women who used the device two to three times per week on various body areas experienced a sustained 48% average reduction in hair count after six weeks of use. Studies show these results to be as efficacious and safe as professional light-based systems.

Consumer response to the No! No! has been strong. In May 2006, Radiancy’s distributor in Europe ran a trial late night television commercial to test consumer interest. The launch of the product via televison sales was later expanded to retail, where, according to the com­pany, during the first week of the test, 10,000 units were sold. By September, more than 100,000 orders had been taken in Spain alone with a run rate of 20,000 devices per week. The unit is priced at $250 to $300, with replacement heads (which are required roughly every 2 months) priced at $10. No! No! is currently available in Chile, Mexico, Argentina, Peru, Uruguay, Spain, Portugal, Germany, Greece, Belgium, Australia, Taiwan, Korea, and the United States, with another 12 planned launches by the end of 2007. More than 700,000 devices have been sold as of May 2007, according to Radiancy’s President and CEO, Dr. Dolev Rafaeli.

Two other home-use devices incorporate a modified version of the LHE (a proprietary and patented combination of Light-and-Heat Energy) technology that Radiancy calls LHE Micro Phototherapy. This adaptation utilizes lower-energy fluence, providing greater safety for consumer use. The Facial Skincare Device (FSD) was cleared in 2006 by FDA for skin rejuvenation, and Clear Touch Lite (CTL) was cleared in 2006 for acne treatment. Both are being sold worldwide. The FSD is a continuous pulsed-light system that delivers light in the 400-1200 nm wavelength range to a large 14 mm x 27 mm spot-size treatment area. Fluence ranges from 6 to 12 J/cm2 with 1.6 ms pulse duration. The 2.8 lb device is easily held in the hand, and plugs into a standard electrical outlet. Radiancy says the FSD (which is also called Facial Toning Device or FTD outside the United States) can stimulate collagen production to soften fine lines, homogenize skin tone, decrease pore size, and improve skin texture. Similarly, the CTL is a continuous pulsed-light system that delivers light in the 430 nm-1100 nm wavelength range with a 14 mm x 27 mm spot size. Fluence is 6 J/cm2 with a 1 ms pulse duration. It weighs 2.2 lb and plugs into a standard electrical outlet. Like Radiancy’s professional acne-treatment devices, CTL helps reduce the appear­ance of inflammatory acne lesions.

Radiancy also has other home-device product initiatives.

In Asia, two companies currently sell laser systems for home hair removal: Spectragen – ics and Ya-Man.

Although Spectragenics is relatively new, its founders have a long history in the aes­thetics industry, having developed the highly successful and technologically innovative LightSheer diode laser for professional hair removal in the early 1990s. They subsequently sold the technology to Palomar Medical, and Palomar divested to Coherent Medical, which in turn merged with ESC to form Lumenis. LightSheer remains one of the indus­try’s top-selling professional laser hair-removal systems, although Spectragenics focuses entirely on the emerging home market, selling a diode laser home hair-removal device in Japan. Available for roughly three years, the product generated approximately $3.0 mil­lion in sales in 2006. The company is working to expand distribution for the i-epi, but as of July 2007, the product had not obtained clearance to market either in the United States or in Europe.

Tokyo-based Ya-Man offers a variety of home-use devices for skin care, hair care, and analysis of body fat. Founded in 1969, the privately held company was the first Japanese manufacturer to introduce professional electrolysis for hair removal in Japan. With more than 400 patents pending, Ya-Man’s technology-based products are sold worldwide in retail stores, salons, mail order, and television shopping channels. Ya-Man has introduced a light – based home hair-removal device in Asia, and is expected to eventually obtain FDA approval to sell the product in the United States.

Palomar Medical Technologies, one of the industry’s oldest manufacturers of profes­sional aesthetic laser equipment and an early technology pioneer, is also working on a home-use device for hair removal. In February 2003, Palomar signed a development agree­ment with razor maker Gillette (which has since been acquired by Procter & Gamble), wherein Gillette would provide $7 million in funding and work with Palomar over a 30-month period to develop a patented self-use device for women. In June 2004, the com­panies extended their relationship, with Gillette agreeing to fund a further $2.1 million through a planned project completion in August 2006. The collaboration extends Palomar’s own efforts to develop a home-use hair-removal device, which date back to the late 1990s. In December 2006, Palomar announced that FDA had cleared its home device for market­ing. While the product had not been introduced as of mid-2007, a high-profile launch is expected shortly that will draw national attention to these new types of devices.

In February 2007, Palomar and Gillette extended their agreement to develop an addi­tional home use, light-based hair-removal device for women. Under the 11-month agree­ment, Gillette will provide Palomar with development payments of $1.2 million and an additional $300,000 upon the completion of certain deliverables.

Palomar is also working with Johnson & Johnson to develop home-use devices for skin rejuvenation, acne treatment, and cellulite reduction. In September 2004, the two compa­nies signed an agreement wherein Johnson & Johnson would fund development and then (presumably) market a product upon FDA approval. While the program is ongoing, Palo – mar has not publicly released any details regarding its progress.

Texas-based Tyrell was founded in 2002 to market a novel device for home treatment of acne. The company’s product, Zeno, utilizes proprietary ClearPoint technology to kill acne-causing bacteria. It does this through the delivery of precisely controlled heat in a replaceable treatment tip that heats to 118.5 degrees. In one clinical trial, 90% of pimples treated with the device demonstrated improvement or resolution within 24 hours. When Zeno was first launched in 2005, it was sold exclusively through dermatologists’ offices and medispas. The following year, however, Tyrell introduced two new versions, Zeno PRO and Zeno MD, which contained higher treatment counts. The full product line now includes original Zeno, a 60-treatment count device priced at $149; Zeno PRO, a 90-treatment count device with carrying case priced at $185; and Zeno MD, a 150-treat­ment count device with carrying case costing $200. The new models also feature new product colors.

Photo Therapeutics Limited, a UK-based company, is also getting ready to launch an advanced home-use device. Like its professional equipment, the company’s home device would be based upon light emitting diode (LED) technology to stimulate collagen regen­eration. Photo Therapeutics’ President, Sue D’Arcy, says that its first device will address skin rejuvenation and acne, with a scheduled launch in 2007. It will be priced at few hun­dred dollars and will be distributed by a group of marketing partners. The company is also planning to investigate the ability of its home-use device to address cellulite. Photo Thera­peutics has obtained FDA approval for a similar home-use product for wound healing.

Although it is still a relatively young company, Syneron has quickly established a lead­ing position in the market for professional light-based aesthetic devices with a series of multifunctional platforms that combine the company’s unique broad spectrum light/ bi-polar RF (ELOS) technology. The devices address all the leading aesthetic applications, including hair removal, skin rejuvenation, skin tightening, acne reduction, treatment of vascular lesions, removal of tattoos, and pigmented lesions, as well as body shaping and skin tightening.

In early 2007, the company announced a partnership with Procter & Gamble (P&G) to develop skin-rejuvenation products for the home market, and is currently conducting early stage clinical studies with a prototype device. Syneron will be responsible for product development while P&G will handle marketing and distribution. Although P&G will ulti­mately set the prices, Syneron has stated that the device will probably be priced less than $500 and there could be a disposable component.

Aesthera, the technology pioneer which developed photopneumatic therapy for profes­sional aesthetic treatment, is also working on a home-use device. Company president Alon Maor says a home system would use photopneumatic technology, but unlike other home units, would not merely represent a scaled-down version of professional devices. As of mid-2007, the company has demonstrated proof of concept and has submitted data in pur­suit of intellectual property protection. Its first application will be treatment of the skin in a comprehensive procedure that Maor says goes beyond skin rejuvenation to address both medical and cosmetic deficiencies. The company expects to begin commercialization toward late 2008 or early 2009; devices would be priced at “a few hundred dollars” and as with Aesthera’s professional systems, would include a disposable component.

Photopneumatic technology combines broadband light with pneumatic (vacuum) energy; the vacuum stretches the skin, increasing its surface area as well as the amount of energy transmitted to the target. This enables treatment for hair removal, skin rejuvenation, reduc­tion of pigmented lesions, and vascular lesions that the company says is uniquely safe, painless, and up to seven times faster than conventional light-based hair-removal therapies.

Candela is one of the oldest and most established aesthetic laser companies, with a broad range of professional products that address hair removal, skin rejuvenation, skin tighten­ing, acne reduction, treatment of vascular lesions, as well as removal of tattoos, and pig­mented lesions. The company’s interest in the home-use market is relatively recent but its significant resources could lead to the quick development of a product.

In March 2007, Candela acquired Inolase, a developer of Serenity Pneumatic Skin Flat­tening (PSF) technology. This technology allows painless, more effective, and safer laser and intense pulsed light (IPL) treatments even at high energy levels. The PSF provides multiple advantages in a single step: painless treatments by activation of a natural pain blocking mechanism; blood expulsion from treatment zone for better light penetration, and improved efficacy; no erythema. The PSF’s vacuum system works with or without gel, and can be mounted on any laser/IPL handpiece for fast and convenient operation. Candela has indicated that this approach may have applications in professional as well as home-use devices. The company appears to be committed to this application, reportedly allocating $10.5 million of the $16.8 million it paid, to acquire Inolase to “goodwill” associated with the technology’s applicability to home use.

Spun out of medical ultrasound developer Guided Therapy Systems, Ulthera is focused on ultrasonic body-shaping devices for the professional market. The company has devel­oped the Ultrasite GT Device, a platform of ultrasound instrumentation that utilizes dispos­able probes to apply energy below the skin’s surface, while sparing the intervening tissue such as the epidermis. The depth and precision of energy deposition is reportedly unprec­edented, and the device’s imaging capability provides a significant advantage over alternative technologies. Ulthera is expected to introduce its first professional product in 2008, and its researchers are also working on a smaller home-use device which would be launched after the professional system. To launch this product, another company has been spun out from the Guided Therapy Systems group.

Xthetix will focus on commercial applications of Ulthera’s technology for the home market. The company’s first product will be for acne treatment and prevention, says Ulthera’s President, Brian O’Connor. It has the ability to prevent the occurrence of acne by inhibiting sebaceous gland function, using heat, he says, without undesirable side effects. Additional devices in the pipeline target skin rejuvenation, hair removal, and inflammation – related skin diseases such as rosacea. Like Ulthera’s professional device, home-use units produced by Xthetix will include both platforms and disposable components.

First-Generation Home-Use Devices

The home aesthetic device market is either extremely large or quite small, depending on how it is defined. A large number of manufacturers have long offered a variety of relatively low-technology products intended to improve skin condition, remove unwanted hair, and address cellulite. Most of these products, however, were not based on medical technology, so the benefit they could provide was limited, and their acceptance has been slow. Table 25.1 shows some of these devices; many have been available for several years, while others are relatively new. Quite a few of the home hair-removal devices have been sold for more than

Table 25.1 Low Tech Home Aesthetic Devices

Type of Device

Application

Selected Manufacturers

Details

Electric clippers

Hair removal

Braun, Emjoi, Panasonic, Philips/Norelco, Wahl, others

Available for many years, widely used

Electric razor

Hair removal

Braun, Panasonic, Philips/ Norelco, Remington, others

Available for many years, widely used

Home electrolysis

Hair removal

Emjoi, Tactica

Newer, limited

(RF)

International, others

acceptance

Rotating coils

Hair removal

Braun, Emjoi, Epilady, Tactica International, others

Newer, limited acceptance

Ionic blemish

Acne

Tactica International,

Newer, limited

remover

others

acceptance

Massager

Cellulite

Guitay*, Tactica International, others

Newer, gaining some acceptance

Ionic facial toner

Skin rejuvenation

Tactica International, Ya-Man, others

Newer, limited acceptance

Microcurrent facial toner

Skin rejuvenation

Skin Star, SLC, others

Newer, limited acceptance but

growing

Microdermabrasion

Skin rejuvenation

Guthy Renker, Johnson & Johnson, Mary Kay, L’Oreal, Procter & Gamble, Zia, others

Relatively new but gaining some acceptance; many new products entering the market

Ultrasonic facial

Skin rejuvenation

Tactica International,

Newer, limited

toner

Ya-Man, others

acceptance

Source: Medical Insight, Inc.

*Device is FDA-cleared for muscular pain relief.

a decade with a few changes. Most are not subject to Food & Drug Administration (FDA), approval and therefore are not required to submit clinical studies demonstrating safety and efficacy. It can be reasonably assumed that such devices provide little significant benefit and in fact, most of the home hair-removal systems offer only temporary hair removal.

Light-Based Devices for At-Home Use

Michael Moretti

Medical Insight, Inc., Aliso Viejo, CA, USA

24.1 Introduction 517

24.2 First-Generation Home-Use Devices 518

24.3 Next Generation Home-Use Devices 519

24.4 Market Growth 524

24.5 Consumer Response 524

24.6 Impact on Physician Practices 525

25.1 I introduction

Consumers have long sought products that would help them look their best, conveniently and affordably. Not only must the prices of professional procedures performed in a salon, spa, or medical office incorporate costs and profit margins associated with these businesses, but also, traveling to these establishments for treatment typically entails an additional com­mitment of time. Therefore, products developed for use at home often meet this need best. In fact, consumers are quite comfortable selecting and using products at home, as most are accustomed to purchasing skin-care and hair-removal products, cosmetics, hair-care prod­ucts, and other personal-care items. Until recently, however, the ability of these products to offer more efficacious results was limited, and consumers seeking more profound results had no choice but to utilize professional services. As aesthetic products and equipment manufacturers increasingly expand beyond professional markets into consumer markets, however, this scenario is changing.

Gurpreet S. Ahluwalia (ed.), Cosmetic Applications of Laser and Light-Based Systems, 517-526,

© 2009 William Andrew Inc.

In the infancy stage, this expansion from professional to consumer markets is the result of three important trends that are poised to continue through the foreseeable future:

1. advancing technology that allows the development of highly effective, yet extremely compact equipment;

2. rising competition and market saturation in the professional device sector, leading manufacturers to seek growth in the larger consumer sector;

3. rising interest in aesthetic treatments among the general public.

While the emerging new aesthetic devices for home use will offer significantly more benefit than home-use products available earlier because they will be based on technology developed for professional aesthetic practitioners, they will nonetheless not compete directly with professional treatments. This is because the new home-use devices will deliver lower levels of energy to provide the highest possible level of safety. Further, as profes­sional equipment continues to advance, the capabilities available to physicians and other practitioners will continue to expand.

“Home devices will have less energy,” says Syneron’s Chief Marketing Offi­cer, Mark Tager, MD. “They’re working at a different scale than professional treatments, at which the energy is at a very therapeutic level for immediate effi­cacy. We’ll see these products being very supportive of professional treatments, such as in maintenance programs. People get into regimens, many of which are approved by their physicians, for skin rejuvenation and skin tightening to keep them looking young. We see home devices as being supportive of good skin maintenance and enhancing awareness of the professionals’ role in the skin care process.”

Therefore, home devices are expected to address a different need than professional services.

This type of differentiation has also been observed in the relatively recent introduction of home microdermbrasion kits, which appeal in large part to consumers who purchase drug-store cosmetics, and are highly price sensitive. This group also includes teens and senior citizens, many of whom like to experiment with new skin-care products, but are not comfortable visiting a professional for treatment. However, James Bartholomeusz, Syner­on’s Director of Product Development, notes that home microdermabrasion kits have a problem differentiating products since they cannot show enhanced benefits. Because of this, he says, they are less likely to be recommended by physicians.

Safety Administration and Training

The practical implementation of a laser-safety program, which includes a laser-safety training program, cannot be treated in detail here. Other reviews of the subject treat these aspects in detail [1,4,10-18]. Clearly, the design of a safety program depends largely on the size of the institution and the variety and the number of lasers in use. An office practice might only have a safety SOP and a designated LSO; a large institution frequently benefits from a laser-safety committee. In the end, the importance of a well-trained staff cannot be over emphasized. Accidents can only be prevented by a well-trained staff and an adminis­trative policy that encourages a sustained effort toward safe laser use.

24.3 Conclusions

The potential exposure levels to the eye and skin from scattered IPL and laser radiation from most dermatologic laser applications are substantially below a threshold for injury, and only the direct beam or specular reflections are of concern. Only with UV lasers should one be seriously concerned with chronic exposure and delayed effects. The cosmetic laser and IPL user can be assured that today a consensus exists almost worldwide regarding the appropriate laser-safety measure to preclude injury from acute or chronic effects. Proce­dural controls requiring the use of appropriate eye protection when needed, and control of vaporized tissue byproducts requires both a well-trained operator-user and any assisting staff. As with many other applications of lasers in industry and research, laser-safety train­ing is of crucial importance.

Non-Beam Hazards

As with other electrical or electronic medical equipment, lasers and IPL systems in the clinical or spa environment may pose electrical safety problems as well. Potential hazards of electrical shock exist, requiring appropriate grounding, and other electrical safety laser use, and biomedical engineers and medical electronics technicians familiar with safe instal­lation of electrical and electronic equipment in the hospital, clinical, or spa environment should have no difficulty in providing guidance for the safe electrical installation and use of laser equipment [1,10]. Only trained service personnel should access the high-voltage power supplies employed with IPL and flashlamp-pulsed lasers, since capacitor discharges can be lethal. Stored charge, even after the system is disconnected at the wall-plug, have produced lethal discharges.

Tissue-ablative laser procedures—just as with electrosurgical techniques—can produce potentially hazardous airborne contaminants from the photovaporization of tissues. Unfor­tunately, the vaporized tissue (“smoke”) from laser surgery has often been referred to as “laser smoke” or the “laser plume,” suggesting that it is unique to laser surgery. This empha­sis on the laser origin has frequently led to the result that vaporized tissue fragments from pyrolysis products of tissue from electrosurgery have been overlooked as having the same degree of hazard. Vaporized tissue in sufficient quantities must receive special attention, and local exhaust ventilation almost always will be required [1,33]. The pyrolysis products are similar to those resulting from the barbecuing of meats. They contain toxic by-products and known carcinogens such as nitrosamines. A number of studies have measured the concen­tration of potentially hazardous airborne contaminants in conventional laser-operating rooms, with the result that concentration are shown to be kept below permissible concentrations with appropriate exhaust ventilation [1]. The studies of both the chemical toxicity of pyrol­ysis products and of the potential viability of infectious particulates (e. g., viral fragments) have shown real cause for concern, unless very good exhaust ventilation and respiratory protection are employed [33-35].

Laser Hazard Classification

As noted, any CW visible laser (400-700 nm) that has an output power <1.0 mW is termed a Class 2 (low-risk) laser, and could be considered more or less equivalent in risk with staring at the sun, at a tungsten-halogen spotlight, or at other bright lights that can cause a photic maculopathy (central retinal injury). Only if one purposely overcomes their natural aversion response to bright light, can a Class 2 laser pose a real ocular hazard. An aiming beam or alignment laser operating at a total power above 1.0 mW would fall into hazard Class 3, and could be hazardous even if viewed momentarily within the aversion response time. A subcategory of Class 3, termed Class 3R (formerly 3A in the United States), consists of lasers from 1-5 mW in power, and these lasers pose a moderate ocular hazard under viewing conditions, where most of the beam enters the eye. Class 3b is when the subcategory that comprises, among certain pulsed lasers, CW visible lasers that emit 5-500 mW output power. Even momentary viewing of Class 3b lasers is potentially haz­ardous to the eye.

Only lasers that are totally enclosed or that emit extremely low output powers fall under Class 1 and are safe to view. Any CW laser with an output power above 0.5 W (500 mW) falls under Class 4. Class 4 lasers are considered to pose skin or fire hazards as well as severe eye hazards, if not properly used. The purpose of assigning hazard classes to laser products is to simplify the determination of adequate safety measures, that is, Class 3a measures are more stringent than Class 2 measures, and Class 4 measures are more strin­gent than Class 3b measures. Virtually, all surgical lasers fall into Class 4, although the ophthalmic Nd:YAG photodisruptor is one example of a Class 3B surgical laser. Low-Level Laser Therapy (LLLT) lasers and LED arrays that employ nonthermal effects to stimulate or “biomodulate” cells in the dermis and epidermis are frequently Class 3B—or even Class 3R laser products, or Risk Group 2 lamp products.