Product Code: KCX FDA class 1 21 CFR 878.5360

Epilator, High Frequency, Tweezer-Type

General, Plastic Surgery

A tweezer-type high-frequency epilator is an electrosurgical device that uses tweezers or forceps-like electrodes to conduct high-frequency current through the hair shaft to the follicle, thermally impairing the hair root for the purpose of hair removal. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls and not requiring premarket notification. Product code KCX is regulated under 21 CFR 878.5360 in the General, Plastic Surgery medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: KCX
Device Class: FDA class 1
Regulation Number: 878.5360
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K973773	DAPELLE HAIR REMOVER	Dec 17, 1997	Substantially Equivalent	Wellquest Intl., Inc.
K973340	TWEEZER-TYPE EPILATOR	Dec 03, 1997	Substantially Equivalent	Mobit, Inc.
K973179	FEMINIQUE SONIC HAIR REMOVER	Oct 30, 1997	Substantially Equivalent	Global TV Concepts, Ltd.
K973174	SONIQUE HAIR REMOVER	Oct 30, 1997	Substantially Equivalent	Global TV Concepts, Ltd.
K972695	FINALLY FREE	Oct 22, 1997	Substantially Equivalent	Mehl/Group Marketing
K970338	TWEEZER-TYPE EPILATOR	Jul 01, 1997	Substantially Equivalent	Igia Direct, Inc.
K935706	EPI 2	Feb 11, 1997	Substantially Equivalent	Universal H.R. System, Inc.
K943872	COMMANDER MARK II HAIR REMOVAL SYSTEM	Oct 26, 1995	Substantially Equivalent	The Helene Edgar Corp.
K952117	EPILATOR	Oct 19, 1995	Substantially Equivalent	Burke Neutech, Inc.
K915845	HAIR TRONICS MODEL HT8000	Jul 29, 1992	Substantially Equivalent	Global Tronics Intl., Inc.
K905125	GUARANTY HAIR REMOVAL SYSTEM	Aug 05, 1991	Substantially Equivalent	Stephens Mfg. Co.
K892514	AHRS EPILATOR 629	Aug 14, 1990	Substantially Equivalent	American Hair Removal System Co.
K851413	EPILATOR 8500	Jun 10, 1985	Substantially Equivalent	Lois Yee Cosmetics, Inc.
K843735	SOFTEPIL	Oct 25, 1984	Substantially Equivalent	Nemectron Medical, Inc.
K843734	NEMDI	Oct 25, 1984	Substantially Equivalent	Nemectron Medical, Inc.
K770791	DEPILATOR, DERMA-I & DERMA-II	Jan 26, 1981	Substantially Equivalent	Electro-Kinetic Eng/Mfg
K802513	DPA 207 PERSONAL	Dec 16, 1980	Substantially Equivalent	Hill, Farrer & Borrill
K782119	DEBUTRON	Feb 26, 1979	Substantially Equivalent	Martin Electric Co.
K780348	EPILATION TYPE DEVICE	May 18, 1978	Substantially Equivalent	Mehl, Thomas L.
K772322	DEPILATORY, ELECTRONIC	Jan 03, 1978	Substantially Equivalent	Dura Corp., The
K771575	ELECTRONIC EIPLATOR MODEL NO. 101	Sep 06, 1977	Substantially Equivalent	Electronic Depilatory, Inc.
K770187	ELECTRONIC DEPILATORY MODEL 303	Feb 23, 1977	Substantially Equivalent	Electronic Depilatory, Inc.
K770186	ELECTRONIC DEPILATORY MODEL 202	Feb 23, 1977	Substantially Equivalent	Electronic Depilatory, Inc.
K761049	KENATRON EPILATOR	Jan 05, 1977	Substantially Equivalent	Epilator Corp.
K760423	ELECTROLYSIS MACHINE (PERMATRON)	Sep 15, 1976	Substantially Equivalent	Epco Hair Removal Corp.