FDA 510(k) clearance

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 to FDA during the dates listed. For needle epilators and electric tweezers, this is no longer required, since the devices have been reclassified by FDA in 1996 and 1998, respectively. Any needle epilator or electric tweezer brought to market since then will not be listed as getting FDA clearance to market, but that does not mean that the device is any more or less safe or effective than devices that were required to get clearance.

Needle-type epilators (KCW)

28 May 1976 to 16 January 1996 (see FDA needle reclassification)

Tweezer-type epilators (KCX)

28 May 1976 to 26 October 1998 (see FDA electric tweezer reclassification)

Lasers/Flash lamps (GEX)

28 May 1976 to present

Microwaves (MWY):

28 May 1976 to present

This site will also have linked data on the following as time permits:

Intended use statements by device

Substantial equivalence listings

Source: FDA 510(k) Database

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