Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

KCW — Predicate Candidate Screening

43 FDA 510(k) clearances under this product code; the 50 most recent screened below.

51 daysmedian FDA review time

153 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days
K954031	COMPU-BLEND EPILATOR	R. A. Fischer Co. Corp.	1996-01-05	130
K952611	STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPIL	Sterex Electrolysis Intl., Ltd.	1995-10-18	133
K945192	HAIR REMOVAL SYSTEM	L.P. Systems Corp.	1995-01-12	80
K943928	APILUS ELECTROPIL	Dectro Intl., Inc.	1995-01-12	153
K943398	THE BLENDTONE ROYALE	Instantron	1994-09-16	64
K943396	THE ELITE SPECTRUM	Instantron	1994-09-16	64
K943399	THE SS-99	Instantron	1994-09-16	64
K941227	SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL	Instantron	1994-08-18	163
K931062	THE VP500 EPILATOR	Instantron	1993-07-08	129
K931063	THE ELITE EPILATOR	Instantron	1993-07-08	129
K931064	THE BLENDTONE EPILATOR	Instantron	1993-07-08	129
K911983	WIZARD STERILIZED ELECTROEPILATION NEEDLE	Skin Deep, Inc.	1991-10-15	165
K904015	ELECTRO-BLEND EPILATOR, MODEL UC-3	A.R. Hinkel Co., Inc.	1990-10-04	34
K895687	D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)	Carol Block, Ltd.	1990-08-09	321
K894771	EPILATION NEEDLE	Precision Electrolysis Needles, Inc.	1989-08-21	26
K893389	MODEL SE-5 EPILATOR	R. A. Fischer Co. Corp.	1989-06-05	35
K883892	BALLET STERILE DISPOSABLE ELECTROLYSIS	Synoptic Products	1988-10-20	36
K884079	MODEL CBX EPILATOR	R. A. Fischer Co. Corp.	1988-10-04	7
K883429	LINDSTROM CORDLESS EPILATOR	A Place of Health & Beauty	1988-09-28	44
K881276	HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS	Ime Co. , Ltd.	1988-05-04	40
K880553	ELECTRONIC EPILATOR	Clareblend, Inc.	1988-02-29	20
K874891	FLEXIE THE COPPER SHANK NEEDLE	Skin Deep, Inc.	1988-01-07	37
K864869	HR-5000 ELECTROSURGICAL DEVICE	Ime Co. , Ltd.	1987-05-19	158
K871372	CB-7 ELECTRONIC EPILATOR	R. A. Fischer Co. Corp.	1987-04-28	21
K864291	HIGH FREQUENCY NEEDLE-TYPE EPILATOR	Multi-Channel Epilator	1986-12-24	54
K864289	MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR	Alexander Thomas, Inc.	1986-12-01	31
K860056	BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)	Berkowits School of Electrolysis, Inc.	1986-02-05	30
K851318	GUIBOR MICROELECTROLYSIS UNIT 18	Galvanic Medical Instruments, Inc.	1985-08-20	140
K843063	ELECTRONIC EPILATOR TS-1	R. A. Fischer Co. Corp.	1984-09-26	51
K834572	EPITRON SUPER	Leo Unlimited, Inc.	1984-04-23	116
K833946	EPILOT 80 S TM	Leo Unlimited, Inc.	1984-04-04	141
K831048	TUFCOTE EPILATION PROBE	Serapis Medical Electronics, Co.	1983-08-12	134
K823674	HIGH FREQUENCY EPILATOR CB-2	R. A. Fischer Co. Corp.	1983-01-14	38
K820650	LPS 1118	L.P. Systems Corp.	1982-04-29	51
K813637	STOLTRONICS-LRS	Stoltronic Systems, Inc.	1982-02-04	36
K811503	EPILATOR, BLEND-MODEL EB-200 & ET-1	Rcx-Western, Inc.	1981-07-10	44
K811501	EPILATOR, MULTIPLE NEEDLE-MODEL EM-20	Rcx-Western, Inc.	1981-07-10	44
K810843	EPILATRON	Electrola	1981-05-08	42
K801555	COMPACT MODEL 360 GALVANIC EPILATOR	Associated Electrolysis Group	1980-08-04	27
K801351	EPILATOR, MODEL CP-16	R. A. Fischer Co. Corp.	1980-07-28	49
K781147	EPILATOR, EASE-MULTI-MODE	Greenleaf-Carter Enterprises, Inc.	1978-10-10	92
K780337	THERMOLYSIS GENERATOR	Clare, Inc.	1978-04-12	41
K780076	EPILATOR, ELECTRONIC MODEL SE-2	R. A. Fischer Co. Corp.	1978-01-24	8

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda