HairFacts | Hair Removal Information
For consumers, by consumers
FDA regulation numbers FDA classifies all devices under regulation numbers and corresponding three-letter product codes. Hair removal devices are classified in the Federal Register under the three regulation numbers below. Note the difference in wording between intended uses for needle-type and tweezer-type epilators, marked in orange. Docket 97N-0199 changed the wording of electric tweezer device … Continue reading “FDA regulation numbers”
FDA 510(k) intended use statements Below is a list of light-based hair removal devices cleared by FDA. The intended use of each is quoted verbatim from FDA clearances, followed by the date the clearance was issued. Some devices have more than one intended use, because they submitted for additional clearance. Nd:YAG lasers Ruby lasers Alexandrite … Continue reading “FDA 510(k) Intended use statements”
FDA reclassification of needle epilators The following is edited text of a ruling made by FDA on 16 January 1996, reclassifying the needle epilator device. The relevant passage is in bold at the end (emphasis mine). [Federal Register: January 16, 1996 (Volume 61, Number 10)] [Rules and Regulations] [Page 1117-1126] From the Federal Register Online … Continue reading “FDA reclassification of needle epilators”
FDA 510(k) submissions Beginning on 28 May 1976, FDA began requiring clearance to market certain hair removal devices. To get clearance, a manufacturer had to show that their device is "substantially equivalent" to a device that was on the market prior to 28 May 1976. The following devices have been required to submit 510(k) data … Continue reading “FDA 510(k) clearance”
eBay eBay is a popular online auction site. It is also the distributor of choice for several doubtful hair removal products. eBay has been notably unresponsive to attempts to get doubtful products taken from their site. Hair removal products sold on eBay should be avoided unless you have confirmed they can work as claimed. Below … Continue reading “eBay (WARNING!)”
My #1 question: Have you heard of ________? Probably. Use the search feature to see what comes up. Below are a few of the “have you heard of” questions I get a lot. If you aren’t finding the information you need on this site, please feel free to ask on my hair removal forum. Methods … Continue reading “Frequently-asked hair removal questions”
Medicam, Inc. Medicam is a Canada-based company that sells a number of devices promoted as lasers through a website, including "breast enhancement" lasers and hair removal devices. Several hair removal products that have been sold by Medicam should be avoided by consumers. Contact information Address: 5285 Queen-Mary, Montreal (Quebec), H3W 1Y3 CANADA Phone: 514-737-0404 Phone: … Continue reading “Medicam/IKYT”
Basic facts: Photolysis HR is basically just a marketing term for a flash lamp hair removal procedure using multiple pulses. The treatments, sold at the California-based Institute of Laser Medicine (ILM) are certainly overhyped by the physician/salesman offering the treatments. Is it better than other flash lamps like EpiLight, or is it better than lasers … Continue reading “Photolysis HR”
On 6 December 2001, a lawyer for Photolysis HR sent me a letter threatening legal action for making comments critical of certain promotional claims on their website. December 6, 2001 BY LETTER AND EMAIL Ms. Andrea James P.O. Box 13217 Chicago , IL 60613 PERSONAL AND CONFIDENTIAL NOT FOR PUBLICATION Re: Our File: IRA 9.0-001 … Continue reading “Photolysis HR threatens legal action”
In the past couple of years, a number of hair removal sites have popped up which look like they are made by consumers, or look like they don’t sell anything. Well, I’m tired of this misleading practice, so here’s the scoop on who’s behind some of the popular sites out there. I’ve even graded them … Continue reading “Hair removal website ratings”
