Since the advent of the first FDA-approved laser hair-removal system in 1995, its popularity has made laser hair-removal a financial cornerstone for many dermatologists and plastic surgeons. The original laser hair-removal machine was The Soft Light Hair Removal System developed by Thermolase Corporation. Since then the growing popularity of and demand for this treatment from eager consumers reading ads and articles in fashion magazines has prompted many laser manufacturers to seek FDA clearance for their laser hair-removal machines. The market is growing so quickly that the FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change. However, to learn if a specific manufacturer has received FDA clearance, you can check the FDA Web site at www. fda. gov/cdrh/databases. html. You will need to know the manufacturer or device name of the laser. You can also call FDA’s Center for Devices and Radiological Health, Consumer Staff, at 1-888-INFO-FDA or (301) 827-3990, or fax your request to (301) 443-9535 (Source: FDA Center for Devices and Radiological Health, Laser Facts, May 2001, online at www. fda. gov/cdrh/consumer/laserfacts. html).
One of the significant FDA regulations regarding all companies that promote approved laser hair-removal systems is that “manufacturers may not claim that laser hair removal is either painless or permanent…. The specific claim granted is ‘intended to effect stable, longterm, or permanent reduction’.. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing after a treatment regime, which may include several sessions. The number of hairs regrowing must be stable over time—greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area.” That is a very convoluted way of saying that laser hair removal is not permanent and that there are no studies showing it to be so even after several treatments. However, the consumer is usually not told what the FDA’s regulation verbiage is.
When laser hair-removal arrived on the scene, many exaggerated, largely unsubstantiated claims about its efficacy, risks, side effects, and long-term effects were asserted (Source: Journal of Cutaneous Laser Therapy, March 2000, pages 49-50). Far more research has taken place since then and there’s much more data (both clearer and more precise) regarding statistical analysis of performance and adverse outcomes. Several studies have looked at various other laser systems, including some showing more promise for darker skin tones (Source: Annals of Plastic Surgery, October 2001, pages 404-411).
The risks in laser hair removal can include skin discoloration (either darkening or lightening of skin), swelling, inflammation, and infected hair follicles. Laser hair removal is particularly problematic for those with tans or darker skin colors (Source: Cosmetic Dermatology, November 2001, pages 45-50). Because of the potential for complications and the plethora of hair-removal machines available, it is essential to have this procedure performed by a physician who is familiar with the research and who can make the correct choice about which procedure is best for you.