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.
 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.
 Based on the thermal properties of the target and chromophore, the tempera
ture of pigmented area absorption loss T1max, temperature of target damage
VelaSmooth and TriActive laser systems differ only in that VelaSmooth incorporates radiofrequency into its protocol, while TriActive incorporates superficial cooling.
 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
 Domestic manufacturers introducing a finished device51 into the US market;
 Specification developers introducing a finished device to the US market;
 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.
 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
 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
 Promote or test-market an investigational device, until after FDA has approved the device for commercial distribution.
 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.