Atlas FDA

KCW

43 FDA 510(k) clearances · Product code

51 daysmedian time to decision
153 days90th percentile
43clearances measured

FDA profile

Official device name
Epilator, High Frequency, Needle-Type
Device class
Class I (low risk)
Regulation
21 CFR 878.5350
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
1993: 1 · 1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
COMPU-BLEND EPILATOR (K954031)R. A. Fischer Co. Corp.1996-01-05
STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION (K952611)Sterex Electrolysis Intl., Ltd.1995-10-18
HAIR REMOVAL SYSTEM (K945192)L.P. Systems Corp.1995-01-12
APILUS ELECTROPIL (K943928)Dectro Intl., Inc.1995-01-12
THE BLENDTONE ROYALE (K943398)Instantron1994-09-16
THE ELITE SPECTRUM (K943396)Instantron1994-09-16
THE SS-99 (K943399)Instantron1994-09-16
SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL (K941227)Instantron1994-08-18
THE VP500 EPILATOR (K931062)Instantron1993-07-08
THE ELITE EPILATOR (K931063)Instantron1993-07-08
THE BLENDTONE EPILATOR (K931064)Instantron1993-07-08
WIZARD STERILIZED ELECTROEPILATION NEEDLE (K911983)Skin Deep, Inc.1991-10-15
ELECTRO-BLEND EPILATOR, MODEL UC-3 (K904015)A.R. Hinkel Co., Inc.1990-10-04
D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE) (K895687)Carol Block, Ltd.1990-08-09
EPILATION NEEDLE (K894771)Precision Electrolysis Needles, Inc.1989-08-21
MODEL SE-5 EPILATOR (K893389)R. A. Fischer Co. Corp.1989-06-05
BALLET STERILE DISPOSABLE ELECTROLYSIS (K883892)Synoptic Products1988-10-20
MODEL CBX EPILATOR (K884079)R. A. Fischer Co. Corp.1988-10-04
LINDSTROM CORDLESS EPILATOR (K883429)A Place of Health & Beauty1988-09-28
HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS (K881276)Ime Co. , Ltd.1988-05-04
ELECTRONIC EPILATOR (K880553)Clareblend, Inc.1988-02-29
FLEXIE THE COPPER SHANK NEEDLE (K874891)Skin Deep, Inc.1988-01-07
HR-5000 ELECTROSURGICAL DEVICE (K864869)Ime Co. , Ltd.1987-05-19
CB-7 ELECTRONIC EPILATOR (K871372)R. A. Fischer Co. Corp.1987-04-28
HIGH FREQUENCY NEEDLE-TYPE EPILATOR (K864291)Multi-Channel Epilator1986-12-24
MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR (K864289)Alexander Thomas, Inc.1986-12-01
BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR) (K860056)Berkowits School of Electrolysis, Inc.1986-02-05
GUIBOR MICROELECTROLYSIS UNIT 18 (K851318)Galvanic Medical Instruments, Inc.1985-08-20
ELECTRONIC EPILATOR TS-1 (K843063)R. A. Fischer Co. Corp.1984-09-26
EPITRON SUPER (K834572)Leo Unlimited, Inc.1984-04-23
EPILOT 80 S TM (K833946)Leo Unlimited, Inc.1984-04-04
TUFCOTE EPILATION PROBE (K831048)Serapis Medical Electronics, Co.1983-08-12
HIGH FREQUENCY EPILATOR CB-2 (K823674)R. A. Fischer Co. Corp.1983-01-14
LPS 1118 (K820650)L.P. Systems Corp.1982-04-29
STOLTRONICS-LRS (K813637)Stoltronic Systems, Inc.1982-02-04
EPILATOR, BLEND-MODEL EB-200 & ET-1 (K811503)Rcx-Western, Inc.1981-07-10
EPILATOR, MULTIPLE NEEDLE-MODEL EM-20 (K811501)Rcx-Western, Inc.1981-07-10
EPILATRON (K810843)Electrola1981-05-08
COMPACT MODEL 360 GALVANIC EPILATOR (K801555)Associated Electrolysis Group1980-08-04
EPILATOR, MODEL CP-16 (K801351)R. A. Fischer Co. Corp.1980-07-28
EPILATOR, EASE-MULTI-MODE (K781147)Greenleaf-Carter Enterprises, Inc.1978-10-10
THERMOLYSIS GENERATOR (K780337)Clare, Inc.1978-04-12
EPILATOR, ELECTRONIC MODEL SE-2 (K780076)R. A. Fischer Co. Corp.1978-01-24

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Every clearance here is in the API, with alerts when new ones post.