KCX — Epilator, High Frequency, Tweezer-Type Class I

FDA Device Classification

FDA product code KCX covers "Epilator, High Frequency, Tweezer-Type", a Class I medical device regulated under 21 CFR 878.5360. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification details

Product Code
KCX
Device Class
Class I
Regulation Number
878.5360
Submission Type
510(k) Exempt
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K973773Wellquest IntlDAPELLE HAIR REMOVERDec 17, 1997
K973340MobitTWEEZER-TYPE EPILATORDec 3, 1997
K973179Global Tv ConceptsFEMINIQUE SONIC HAIR REMOVEROct 30, 1997
K973174Global Tv ConceptsSONIQUE HAIR REMOVEROct 30, 1997
K972695Mehl/Group MarketingFINALLY FREEOct 22, 1997
K970338Igia DirectTWEEZER-TYPE EPILATORJul 1, 1997
K935706Universal H.R. SystemEPI 2Feb 11, 1997
K943872Helene EdgarCOMMANDER MARK II HAIR REMOVAL SYSTEMOct 26, 1995
K952117Burke NeutechEPILATOROct 19, 1995
K915845Global Tronics IntlHAIR TRONICS MODEL HT8000Jul 29, 1992
K905125Stephens MfgGUARANTY HAIR REMOVAL SYSTEMAug 5, 1991
K892514American Hair Removal SystemAHRS EPILATOR 629Aug 14, 1990
K851413Lois Yee CosmeticsEPILATOR 8500Jun 10, 1985
K843734Nemectron MedicalNEMDIOct 25, 1984
K843735Nemectron MedicalSOFTEPILOct 25, 1984
K770791Electro-Kinetic Eng/MfgDEPILATOR, DERMA-I & DERMA-IIJan 26, 1981
K802513Hill, Farrer And BorrillDPA 207 PERSONALDec 16, 1980
K782119Martin ElectricDEBUTRONFeb 26, 1979
K780348Mehl, Thomas LEPILATION TYPE DEVICEMay 18, 1978
K772322Dura Corp., TheDEPILATORY, ELECTRONICJan 3, 1978

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.