FDA 510(k) clearances: Electric tweezers 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 26 October 1998, FDA reclassified
electric tweezers and no longer requires them to submit 510(k)
data.
See  FDA electric
tweezer reclassification
FDA agrees: no proof of electric tweezer permanence
This Final Rule reclassifying electric tweezers (Docket 97N-0199)
states:
"FDA acknowledges that there
is no statistically significant scientific data available at
this time to support promotional claims of permanent or long-term
removal of hair through the use of the device."
Unpublished data submitted by electric tweezer makers to FDA
were evaluated and found to be "only suggestive of effectiveness
in permanently removing hair."
FDA classifies electric tweezers as follows:
- Device Classification Name: Epilator, tweezer-type
- Regulation Number: 878.5360
- Product Code: KCX
Product Code KCX
Tweezer-type epilators cleared by FDA, 1976-1998:
Note: Any electric
tweezer marketed since 26 January 1998 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 Berkowits
device was cleared as a needle epilator, but is sold currently
as an electric tweezer.
Sources:
FDA Final Rule: electric tweezers reclassified
(text)
FDA Final Rule: electric tweezers reclassified
(pdf)
Releasable 510(k) Database (type in KCX
under Product Code to list all electric tweezer clearances.
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