The FDA does not allow for the marketing of technologies and services that state permanent hair removal. This is because most technologies provide for permanent reduction in hair growth 90% of the time, give or take + or – 10%.
So we won’t say permanent removal without acknowledging the possibility of that 10%. The LightSheer diode laser is the first diode laser that has been approved for permanent hair reduction by the FDA.
Permanent hair reduction as defined by the FDA, is the long-term stable reduction in the number of hairs re-growing after a treatment regime. The number of re-growing hairs must be stable over a time greater than the duration of the complete growth cycle of hair follicles, which varies from 4 – 12 months, according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in a treated area. Blonde white and red hairs do not have enough melanin to target.
In February 1998, the LightSheer system was approved by the Food and Drug Administration (FDA) for permanent hair reduction. The LightSheer diode laser system is intended to effect temporary hair removal, and in turn, also intended to effect stable long-term, or permanent hair reduction through selectively targeting melanin in hair follicles. It is important to note that the FDA does not approve or otherwise endorse lasers, or any other type of hair removal equipment. The FDA issues clearance for its intended use. All lasers must have safety clearance in order to be sold, and some lasers have the additional clearance for permanent hair reduction. When a manufacturer gets safety clearance, they have to state what the machine is used for. Some machines have clearance for hair removal (just like a pair of tweezers would have if they were required to have safety clearance first.) The clearance for permanent is what all manufacturers want, and NO laser or light based device has clearance for permanent removal. The only form of hair removal that has clearance for permanent hair removal is electrolysis.
Electrologists lobbied to the FDA to have the clearance for the term, due to the laser’s inability to treat white grey or blonde hairs. Electrologists, however cannot remove all of the hairs in one session, and if they don’t want to scar your skin it takes multiple treatments (if not years) to remove the hair in the treatment area. I think the term ‘permanent removal’ needs to be changed to ‘permanent reduction’ for BOTH laser and electrolyis because it is the most accurate description. Regardless of any term, it serves to confuse the consumer in choosing a proper form of hair removal and choosing the proper laser AND laser technician to perform the treatments. We hope you choose our facility and the LightSheer diode laser, the gold standard, to serve your concerns about eliminating unwanted hair.
Please note that clearance does not mean that a certain laser is going to work for you. Studies conducted by the manufacturer and submitted to the FDA do prove that the laser worked for a majority of the test groups, however these results vary from individual to individual and other factors, (such as your laser operator) weigh heavily on the results.
You can check the FDA’s database for clearances as they are added and issued. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm