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.

Device	Company	Date cleared	510(k)
Compu-Blend Epilator	R.A. Fischer	01/05/96	K954031
Sterex Sterile Disposable Needle	Sterex	10/18/95	K952611
Apilus Electroepil	Dectro	01/12/95	K943928
Hair Removal System	L.P. Systems	01/12/95	K945192
Elite Spectrum	Instantron	09/16/94	K943396
Blendtone Royale	Instantron	09/16/94	K943398
SS-99	Instantron	09/16/94	K943399
Shortwave Epilator	Instantron	08/18/94	K941227
VP500 Epilator	Instantron	07/08/93	K931062
Elite Epilator	Instantron	07/08/93	K931063
Blendtone Epilator	Instantron	07/08/93	K931064
Wizard Sterilized Electroepilation Needle	Skin Deep	10/15/91	K911983
Electro-Blend Epilator, Model UC-3	A.R. Hinkel	10/04/90	K904015
D'Plume XXII Photocoagulator^{^[1]}	Carol Block	08/09/90	K895687
Epilation Needle	Precision	08/21/89	K894771
Model SE-5 Epilator	R.A. Fischer	06/05/89	K893389
Ballet Sterile Disposable Needle	Synoptic Products	10/20/88	K883892
Model CBX Epilator	R.A. Fischer	10/04/88	K884079
HR-5000 Electosurgical Device	IME Co.	05/04/88	K881276
Electronic Epilator	Clareblend	02/29/88	K880553
Flexie Copper Shank Needle	Skin Deep	01/07/88	K874891
HR-5000 Electosurgical Device	IME Co.	05/19/87	K864869
CB-7 Electronic Epilator	R.A. Fischer	04/28/87	K871372
High Frequency Needle-Type Epilator	Multi-Channel (Gentronics)	12/24/86	K864291
Microprocessor Control/MNG Epilator	Alexander Thomas	12/01/86	K864289
Berkowits 2200 Short Wave Epilator^{^[2]}	Berkowits	02/05/86	K860056
Guibor Microelectrolysis Unit 18	Galvanic Medical	08/20/85	K851318
Electronic Epilator TS-1	R.A. Fischer	09/26/84	K843063
Epitron Super	Leo Unlimited	04/23/84	K834572
Epilot 80 S TM	Leo Unlimited	04/04/84	K833946
Tufcote Epilation Probe	Serapis Medical	08/12/83	K831048
High Frequency Epilator CB-2	R.A. Fischer	01/14/83	K823674
LPS 1118	L.P. Systems	04/29/82	K820650
Stoltronics-LRS	Stoltronic Systems	02/04/82	K813637
Epilator, Multiple Needle-Model EM-20	RCX-Western	07/10/81	K811501
Epilator, Blend-Model EB-200 & ET-1	RCX-Western	K811503	07/10/81
Epilatron	Electrola	05/08/81	K810843
Compact Model 360 Galvanic Epilator	Associated Electrolysis	08/04/80	K801555
Epilator, Ease-Multi-Mode	Greenleaf-Carter	10/10/78	K781147
Thermolysis Generator	Clareblend	04/12/78	K780337
Epilator, Electronic Model SE-2	R.A. Fischer	01/24/78	K780076

^{^[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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