Epilator, High Frequency, Needle-type
General, Plastic Surgery · 21 CFR 878.5350
Recent MDR events
8 adverse event reports on file
- SKIN CLASSICFeb 12, 2020InjuryClareblend, Inc.MW5092983
- SKIN CLASSICJan 28, 2020InjuryClarebend, Inc.MW5092595
- NO NO HAIROct 10, 2015InjuryMW5057160
- VASCUTOUCHJul 15, 2014InjuryDectro International Company3005327046-2014-00001
- PULSE LIGHTMar 24, 2003UnkMW4003504
- LIGHT SHEER LASER DIODEJun 24, 2002Injury*MW1025413
- PROTEUS E.P. 2000Nov 18, 1994InjuryProteus Epilators, Inc.MW1004085
- NO NEEDLE ELECTROLYSISOct 1, 1993American Hair Removal SystemMW4000051
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
28 firms currently registered for this product code
Yongkang Dahua Industry&trade Co.,ltd
yongkang Zhejiang, CN
Silhouet-tone Usa
Miami, FL, US
Permanence Wholesale Pty Ltd
Sydney New South Wales, AU
Silhouet-tone Corporation
LAVAL Quebec, CA
Optego Vision Usa, Inc.
Tucson, AZ, US
Sterlab
VALLAURIS Alpes-Maritimes, FR
Sterex Electrolysis Intl., Ltd.
BIRMINGHAM, GB
Dectronique (1984) Inc. Dba Dectro International
QUEBEC, CA
Synergy Health Sterilisation Uk Ltd
Swindon Wiltshire, GB
Sterlab
SIGNES Var, FR
Active Optical Systems, Ltd./efraim Bidas
PETACH-TIKVA Central, IL
Bestway Plastic And Metal Products Ltd.
Dongguan Guangdong, CN
Aopu Lighting (jinyun) Co., Ltd.
Lishui Zhejiang, CN
Instantronics
Durham, NC, US
Agnes Medical Co.,ltd
Seongnam-si Gyeonggi, KR
Classys Inc
Anyang-si Gyeonggi, KR
Weifang Dragonfly Electronic Technology Co., Ltd.
Weifang Shandong, CN
Synergy Health Sterilisation Uk Ltd
Berkshire Reading, GB
Alira Medical Devices Llc
Rancho Cucamonga, CA, US
Infinity Gold Investment Corp
Tampa, FL, US
Micro-mega Sa
BESANCON Doubs, FR
Ballet Technologies Llc.
Hanover, NH, US
510(k) clearances
43 clearances for this product code
- R. A. Fischer Co. Corp.Jan 5, 1996
K954031 · COMPU-BLEND EPILATOR
- Sterex Electrolysis Intl., Ltd.Oct 18, 1995
K952611 · STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION
- L.P. Systems Corp.Jan 12, 1995
K945192 · HAIR REMOVAL SYSTEM
- Dectro Intl., Inc.Jan 12, 1995
K943928 · APILUS ELECTROPIL
- InstantronSep 16, 1994
K943398 · THE BLENDTONE ROYALE
- InstantronSep 16, 1994
K943396 · THE ELITE SPECTRUM
- InstantronSep 16, 1994
K943399 · THE SS-99
- InstantronAug 18, 1994
K941227 · SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL