FDA 510(k) clearance: Tweezer-type epilators

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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Unpublished data submitted by electric tweezer makers to FDA were evaluated and found to be "only suggestive of effectiveness in permanently removing hair."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.