FDA 510(k) clearance: Tweezer-type epilators

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Unpublished data submitted by electric tweezer makers to FDA were evaluated and found to be "only suggestive of effectiveness in permanently removing hair."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

Device Company Date cleared 510(k) #
Dapelle Hair Remover Wellquest International 12/17/97 K973773
Emjoi Beauty [?] Mobit 12/03/97 K973340
Feminique Sonic Hair Remover Global TV Concepts 10/30/97 K973179
Sonique Hair Remover Global TV Concepts 10/30/97 K973174
Finally Free Mehl/Group Marketing 10/22/97 K972695
IGIA System IGIA Direct 07/01/97 K970338
Epi 2 Universal Hair Removal System 02/11/97 K935706
Commander Mark II System The Helene Edgar Corporation 10/26/95 K943872
Epilator Burke Neutech 10/19/95 K952117
Hair Tronics Model HT8000 Global Tronics International 07/29/92 K915845
Guaranty Hair Removal System Stephens Manufacturing 08/05/91 K905125
AHRS Epilator 629 American Hair Removal System 08/14/90 K892514
Berkowits 2200 Short Wave Epilator [2] Berkowits 02/05/86 K860056
Epilator 8500 Lois Yee Cosmetics 06/10/85 K851413
Nemdi Nemectron Medical 10/25/84 K843734
Softepil Nemectron Medical 10/25/84 K843735
Depilator, Derma-I & II Electro-Kinetic Eng/Mfg 01/26/81 K770791
DPA 207 Personal [Hill, Farrer & Borrill] 12/16/80 K802513
Debutron Martin Electric 02/26/79 K782119
Epilation Type Device Mehl, Thomas L. 05/18/78 K780348
Depilatory, Electronic Dura Corporation 01/03/78 K772322
Electronic Depilatory Model 101 Electronic Depilatory 09/06/77 K771575
Electronic Depilatory Model 202 Electronic Depilatory 02/23/77 K770186
Electronic Depilatory Model 303 Electronic Depilatory 02/23/77 K770187
Kenatron Epilator Epilator Corporation 01/05/77 K761049
Permatron Electrolysis Machine Epco Hair Removal 09/15/76 K760423

[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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