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Unpublished data submitted by electric tweezer makers to FDA were evaluated and found to be "only suggestive of effectiveness in permanently removing hair."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|
|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 ||Berkowits||02/05/86||K860056|
|Epilator 8500||Lois Yee Cosmetics||06/10/85||K851413|
|Depilator, Derma-I & II||Electro-Kinetic Eng/Mfg||01/26/81||K770791|
|DPA 207 Personal||[Hill, Farrer & Borrill]||12/16/80||K802513|
|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|
 The Berkowits device was cleared as a needle epilator, but is sold currently as an electric tweezer.
Releasable 510(k) Database (type in KCX under Product Code to list all electric tweezer clearances.