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

KCX — Predicate Candidate Screening

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

66 daysmedian FDA review time

490 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K973773	DAPELLE HAIR REMOVER	Wellquest Intl., Inc.	1997-12-17	76
K973340	TWEEZER-TYPE EPILATOR	Mobit, Inc.	1997-12-03	89
K973174	SONIQUE HAIR REMOVER	Global TV Concepts, Ltd.	1997-10-30	66
K973179	FEMINIQUE SONIC HAIR REMOVER	Global TV Concepts, Ltd.	1997-10-30	66
K972695	FINALLY FREE	Mehl/Group Marketing	1997-10-22	96
K970338	TWEEZER-TYPE EPILATOR	Igia Direct, Inc.	1997-07-01	153
K935706	EPI 2	Universal H.R. System, Inc.	1997-02-11	1169
K943872	COMMANDER MARK II HAIR REMOVAL SYSTEM	The Helene Edgar Corp.	1995-10-26	444
K952117	EPILATOR	Burke Neutech, Inc.	1995-10-19	167
K915845	HAIR TRONICS MODEL HT8000	Global Tronics Intl., Inc.	1992-07-29	216
K905125	GUARANTY HAIR REMOVAL SYSTEM	Stephens Mfg. Co.	1991-08-05	264
K892514	AHRS EPILATOR 629	American Hair Removal System Co.	1990-08-14	490
K851413	EPILATOR 8500	Lois Yee Cosmetics, Inc.	1985-06-10	62
K843734	NEMDI	Nemectron Medical, Inc.	1984-10-25	31
K843735	SOFTEPIL	Nemectron Medical, Inc.	1984-10-25	31
K770791	DEPILATOR, DERMA-I & DERMA-II	Electro-Kinetic Eng/Mfg	1981-01-26	1365
K802513	DPA 207 PERSONAL	Hill, Farrer & Borrill	1980-12-16	62
K782119	DEBUTRON	Martin Electric Co.	1979-02-26	61
K780348	EPILATION TYPE DEVICE	Mehl, Thomas L.	1978-05-18	77
K772322	DEPILATORY, ELECTRONIC	Dura Corp., The	1978-01-03	15
K771575	ELECTRONIC EIPLATOR MODEL NO. 101	Electronic Depilatory, Inc.	1977-09-06	21
K770187	ELECTRONIC DEPILATORY MODEL 303	Electronic Depilatory, Inc.	1977-02-23	27
K770186	ELECTRONIC DEPILATORY MODEL 202	Electronic Depilatory, Inc.	1977-02-23	27
K761049	KENATRON EPILATOR	Epilator Corp.	1977-01-05	51
K760423	ELECTROLYSIS MACHINE (PERMATRON)	Epco Hair Removal Corp.	1976-09-15	35

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