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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