Food And Drug Administration
Of The U.S. Department Of
Health And Human Services
The fda-gov website regularly publishes consumer updates, featuring the latest on all FDA-regulated products. What exactly was published on their website http://www.fda-gov/consumer/updates.html about hair removal devices?
Consumer Update number hair062707 was published on 27 June 2007 .
This update featured the latest on all FDA regulated products.
Only the parts of articles specifically relating to certain hair removal methods were copied and posted on this website.
More specifically the articles about radiation devices and their clearance standards can be found on this page.
Below you can read exactly what the USA Department of Health and Human Services’ Federal Department Administration says about it.
FDA-Gov consumer updates of medical lasers
Copied from www.fda-gov/consumer/updates/hair062707.html:
“Medical lasers have been used for dermatology applications such as removal of port wine stains, dark spots, tattoos, acne scars and other blemishes for over a decade. Lasers are used for a growing number of cosmetic procedures including hair removal, treatment of wrinkles, and tooth whitening. For risk information on the specific laser treatment that you are considering, ask your physician or operator for the patient labeling for the laser device.”
“The U.S. Food and Drug Administration (FDA) recognizes electrology as providing permanent hair removal. The FDA identification in Title 21, CFR, Sec. 878.5350 for needle-type epilators is: “a device intended to remove the hair by destroying the dermal papilla of a hair”. As no other device for hair removal has the unique identification of “destroying the dermal papilla of a hair”, only electrologists are allowed to claim permanent hair removal in their advertising”.
Safety standards of radiation-emitting products
Copied from www.fda-gov/Radiation-Emitting Products.html: “All laser devices distributed for both human and animal treatment in the U.S. are subject to Mandatory Performance Standards. They must meet the Federal laser product performance standard and must submit an “initial report” to CDRH’s Office of Compliance prior to distributing the product (see 21 CFR 1000-1040.11).
This performance standard specifies the safety features and labeling that all laser products must have in order to provide adequate safety to users and patients. A laser product manufacturer must certify that each model complies with the standard before introducing the laser into U.S. commerce. This includes distribution for use during clinical investigations prior to device approval.
Certification of a laser product means that each unit has passed a quality assurance test and that it complies with the performance standard. The firm that certifies a laser product assumes responsibility for product reporting, recordkeeping, and notification of defects, noncompliances, and accidental radiation occurrences, as specified in sections 21 CFR 1000-1010.
A certifier of a laser product is required to report the product via a Laser Product Report submitted to CDRH. Reporting guides and related regulatory information are available from the Radiation-Emitting Products. Distribution of any certified laser products internationally would also require submission of the report.”
Medical-device databases and laser hair removal
Copied from www.fda-gov/Medical-Device Databases.html:
“The popularity of laser hair removal has increasingly grown, prompting many laser manufacturers to conduct research and seek FD-gov clearance for their lasers for this indication.
The market is growing so quickly that 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.
To learn if a specific manufacturer has received FDA clearance, you can check FDA’s Website at Medical Device Databases under the 510(k) database. 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 240-276-3103, fax your request to 240-276-3151 or send an e-mail to: DSMICA@cdrh.fda.gov.
Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure.
Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to demonstrate such results. Several manufacturers received FDA permission to claim, “permanent reduction,” NOT “permanent removal” for their lasers.
This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair. The specific claim granted is “intended to effect stable, long-term, or permanent reduction” through selective targeting of melanin in hair follicles.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing 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.
FDA does not make comparisons between systems or how well or safely they work compared to another company’s system. FDA does not recommend one laser system over another. Lasers cleared for body hair removal are also cleared for facial hair removal.”
Epilators: needle, electrolysis and tweezers
Copied from www.fda-gov/Devices&Radiological-Health.html;:
“Needle epilators introduce a fine wire close to the hair shaft, under the skin, and into the hair follicle. An electric current travels down the wire and destroys the hair root at the bottom of the follicle, and the loosened hair is removed with tweezers.
Medical electrolysis devices destroy hair growth with a shortwave radio frequency after a thin probe is placed in the hair follicle. Risks from these methods include infection from an unsterile needle and scarring from improper technique. Electrolysis is considered a permanent hair removal method, since it destroys the hair follicle.
It requires a series of appointments over a period of time.
Tweezer epilators also use electric current to remove hair. The tweezers grasp the hair close to the skin, and energy is applied at the tip of the tweezer. There is no body of significant information establishing the effectiveness of the tweezer epilator to permanently remove hair.”
OK, now you know exactly what the USA Department of Health and Human Services’ Federal Department Administration (FDA-gov) says about radiation devices and their clearance standards.
Now you won’t be fooled any longer with unrealistic claims made by overzealous sales people. Remember – laser may NOT claim permanent hair removal. If it happens, it is a bonus.
Are you looking for some specific information, but don’t know where to look for it? Simply follow this link or type what you are looking for into the Search Box below and click on the search button. You will be taken there.
- Fantastic results can be achieved with photo epilation hair removal. Do you know what photo epilation is?
- Although laser, intense pulsed light (IPL) and electrolysis are all considered to be epilation hair removal methods, they are in a totally different class to the other methods.
- Read up about the various hair removal methods that can be used to get rid of all your unwanted body hair.
Other interesting pages
Go to Hair Removal Systems from FDA-gov
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