Product Code: KCW FDA class 1 21 CFR 878.5350

Epilator, High Frequency, Needle-Type

General, Plastic Surgery

A needle-type high-frequency epilator is an electrosurgical device that uses a fine needle electrode to deliver high-frequency electrical current to individual hair follicles, thermally destroying the follicle to achieve permanent hair removal, used in dermatological or surgical settings. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KCW is regulated under 21 CFR 878.5350 in the General, Plastic Surgery medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

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Basic Information

Product Code: KCW
Device Class: FDA class 1
Regulation Number: 878.5350
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 43 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K954031	COMPU-BLEND EPILATOR	Jan 05, 1996	Substantially Equivalent	R. A. Fischer Co. Corp.
K952611	STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION	Oct 18, 1995	Substantially Equivalent	Sterex Electrolysis Intl., Ltd.
K945192	HAIR REMOVAL SYSTEM	Jan 12, 1995	Substantially Equivalent	L.P. Systems Corp.
K943928	APILUS ELECTROPIL	Jan 12, 1995	Substantially Equivalent	Dectro Intl., Inc.
K943399	THE SS-99	Sep 16, 1994	Substantially Equivalent	Instantron
K943398	THE BLENDTONE ROYALE	Sep 16, 1994	Substantially Equivalent	Instantron
K943396	THE ELITE SPECTRUM	Sep 16, 1994	Substantially Equivalent	Instantron
K941227	SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL	Aug 18, 1994	Substantially Equivalent	Instantron
K931064	THE BLENDTONE EPILATOR	Jul 08, 1993	Substantially Equivalent	Instantron
K931063	THE ELITE EPILATOR	Jul 08, 1993	Substantially Equivalent	Instantron
K931062	THE VP500 EPILATOR	Jul 08, 1993	Substantially Equivalent	Instantron
K911983	WIZARD STERILIZED ELECTROEPILATION NEEDLE	Oct 15, 1991	Substantially Equivalent	Skin Deep, Inc.
K904015	ELECTRO-BLEND EPILATOR, MODEL UC-3	Oct 04, 1990	Substantially Equivalent	A.R. Hinkel Co., Inc.
K895687	D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)	Aug 09, 1990	Substantially Equivalent	Carol Block, Ltd.
K894771	EPILATION NEEDLE	Aug 21, 1989	Substantially Equivalent	Precision Electrolysis Needles, Inc.
K893389	MODEL SE-5 EPILATOR	Jun 05, 1989	Substantially Equivalent	R. A. Fischer Co. Corp.
K883892	BALLET STERILE DISPOSABLE ELECTROLYSIS	Oct 20, 1988	Substantially Equivalent	Synoptic Products
K884079	MODEL CBX EPILATOR	Oct 04, 1988	Substantially Equivalent	R. A. Fischer Co. Corp.
K883429	LINDSTROM CORDLESS EPILATOR	Sep 28, 1988	Substantially Equivalent	A Place of Health & Beauty
K881276	HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS	May 04, 1988	Substantially Equivalent	Ime Co. , Ltd.
K880553	ELECTRONIC EPILATOR	Feb 29, 1988	Substantially Equivalent	Clareblend, Inc.
K874891	FLEXIE THE COPPER SHANK NEEDLE	Jan 07, 1988	Substantially Equivalent	Skin Deep, Inc.
K864869	HR-5000 ELECTROSURGICAL DEVICE	May 19, 1987	Substantially Equivalent	Ime Co. , Ltd.
K871372	CB-7 ELECTRONIC EPILATOR	Apr 28, 1987	Substantially Equivalent	R. A. Fischer Co. Corp.
K864291	HIGH FREQUENCY NEEDLE-TYPE EPILATOR	Dec 24, 1986	Substantially Equivalent	Multi-Channel Epilator
K864289	MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR	Dec 01, 1986	Substantially Equivalent	Alexander Thomas, Inc.
K860056	BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)	Feb 05, 1986	Substantially Equivalent	Berkowits School of Electrolysis, Inc.
K851318	GUIBOR MICROELECTROLYSIS UNIT 18	Aug 20, 1985	Substantially Equivalent	Galvanic Medical Instruments, Inc.
K843063	ELECTRONIC EPILATOR TS-1	Sep 26, 1984	Substantially Equivalent	R. A. Fischer Co. Corp.
K834572	EPITRON SUPER	Apr 23, 1984	Substantially Equivalent	Leo Unlimited, Inc.
K833946	EPILOT 80 S TM	Apr 04, 1984	Substantially Equivalent	Leo Unlimited, Inc.
K831048	TUFCOTE EPILATION PROBE	Aug 12, 1983	Substantially Equivalent	Serapis Medical Electronics, Co.
K823674	HIGH FREQUENCY EPILATOR CB-2	Jan 14, 1983	Substantially Equivalent	R. A. Fischer Co. Corp.
K820650	LPS 1118	Apr 29, 1982	Substantially Equivalent	L.P. Systems Corp.
K813637	STOLTRONICS-LRS	Feb 04, 1982	Substantially Equivalent	Stoltronic Systems, Inc.
K811503	EPILATOR, BLEND-MODEL EB-200 & ET-1	Jul 10, 1981	Substantially Equivalent	Rcx-Western, Inc.
K811501	EPILATOR, MULTIPLE NEEDLE-MODEL EM-20	Jul 10, 1981	Substantially Equivalent	Rcx-Western, Inc.
K810843	EPILATRON	May 08, 1981	Substantially Equivalent	Electrola
K801555	COMPACT MODEL 360 GALVANIC EPILATOR	Aug 04, 1980	Substantially Equivalent	Associated Electrolysis Group
K801351	EPILATOR, MODEL CP-16	Jul 28, 1980	Substantially Equivalent	R. A. Fischer Co. Corp.
K781147	EPILATOR, EASE-MULTI-MODE	Oct 10, 1978	Substantially Equivalent	Greenleaf-Carter Enterprises, Inc.
K780337	THERMOLYSIS GENERATOR	Apr 12, 1978	Substantially Equivalent	Clare, Inc.
K780076	EPILATOR, ELECTRONIC MODEL SE-2	Jan 24, 1978	Substantially Equivalent	R. A. Fischer Co. Corp.