FDA 510(k) clearances: Needle epilators Beginning on 28 May 1976, the US Food and Drug Administration
(FDA) began requiring new medical devices to demonstrate they
were "substantially equivalent" to a product marketed
before 1976.
On 16 January 1996, FDA reclassified
needle epilators and no longer requires them to submit 510(k)
data.
See  FDA needle reclassification
FDA classifies needle epilators and accessories as follows:
- Device Classification Name: Epilator, needle-type
- Regulation Number: 878.5350
- Product Code: KCW
Product Code KCW
Needle epilators and accessories cleared by FDA, 1976-1996
Note: Any needle
epilator marketed since 16 January 1996 will not be listed below,
but that does not mean that the device is any more or less safe
or effective than devices that were required to get clearance.
[1] The D'Plume
XXII device currently marketed is not a needle epilator, but a
photoepilator.
[2] The Berkowits
device currently marketed is not a needle epilator, but an electric tweezer.
Sources:
Releasable 510(k) Database (type in KCW
under Product Code to list all needle epilator and accessory
clearances)
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