The medical device amendments were written to the Federal Food Drug and Cosmetic Act in May 1976. All new medical devices, including lasers became subject to the FDA premarket clearance. The 1976 amendments established a three-tiered system of medical devices, which categorized the thousands of different types of marketed medical devices into three groups—based on […]

The US FDA1 currently regulates the manufacturing and marketing of medical devices in the United States under the Federal Food, Drug and Cosmetic Act2 (FDCA). It was not until 1938 FDCA that medical devices were subject to any type of federal regulation. However, it was nearly four decades later in 1976 that the device regulations […]

Todd J. Banks1 and Gurpreet S. Ahluwalia2 1Regulatory Affairs Manager, The Procter & Gamble Company, Cincinnati, OH 45241, USA 2The Gillette Company, a wholly owned subsidiary of The P&G Company, Needham, MA, USA Before a medical device can be introduced into commerce, the manufacturer or the distribu­tor must receive clearance or approval from the Food […]

The application of PDT to the field of hair removal is in its nascent stages of develop­ment. As discussed in the acne section earlier, studies have demonstrated uptake of ALA into the pilosebaceous unit. In 1990, Divaris and colleagues demonstrated that intraperito­neal injection of ALA resulted in PpIX fluorescence in sebaceous glands and to a […]

For over a century, PDT has been used to treat cutaneous neoplasia, and recently this application has been extended to include photoaging, the cutaneous manifestation of sun- induced aging to the skin. The current protocols in use involve the topical application of ALA for short incubation followed by blue light, LP PDL, or IPL. Among […]

Among all the light sources, IPL combined with ALA PDT has been the most exten­sively studied for use in photorejuvenation; this largely stemming from the fact that IPL has independently been shown to rejuvenate skin while spanning wavelengths that activate PPIX. The advantage of IPL (spanning the 400-1200 nm range) is the ability to target […]

PDL treatment of photoaged skin stemmed from the clinical and histologic collagen changes observed in PDL-treated hypertrophic scars, striae distensae, and acne scars [45-52]. The 585 nm pulsed dye laser (N-lite) at 350 ps and subpurpuric fluences was the first to be studied for photorejuvenation [53]. An early study reported that a single PDL treatment […]

The methylated form of ALA, topical methyl aminolevulinic acid (MAL), has been eval­uated largely in conjunction with red light for the treatment of skin neoplasia, and is FDA – approved for the treatment of AK. MAL and red light demonstrated 69 and 89% clearance of AK in two separate studies at a three-month follow-up [43,41]. […]

Starting in the 1990s, blue light was extensively studied for the treatment of AK due to the superficial localization of these precancerous lesions. The combination of topical ALA for 14-18-hour incubation followed by 1000 seconds of blue light illumination achieved FDA approval for the treatment of AK in 1997 [40]. The Phase III trial, which […]