KCX
25 FDA 510(k) clearances · Product code
66 daysmedian time to decision
490 days90th percentile
25clearances measured
FDA profile
- Official device name
- Epilator, High Frequency, Tweezer-Type
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.5360
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DAPELLE HAIR REMOVER (K973773) | Wellquest Intl., Inc. | 1997-12-17 |
| TWEEZER-TYPE EPILATOR (K973340) | Mobit, Inc. | 1997-12-03 |
| SONIQUE HAIR REMOVER (K973174) | Global TV Concepts, Ltd. | 1997-10-30 |
| FEMINIQUE SONIC HAIR REMOVER (K973179) | Global TV Concepts, Ltd. | 1997-10-30 |
| FINALLY FREE (K972695) | Mehl/Group Marketing | 1997-10-22 |
| TWEEZER-TYPE EPILATOR (K970338) | Igia Direct, Inc. | 1997-07-01 |
| EPI 2 (K935706) | Universal H.R. System, Inc. | 1997-02-11 |
| COMMANDER MARK II HAIR REMOVAL SYSTEM (K943872) | The Helene Edgar Corp. | 1995-10-26 |
| EPILATOR (K952117) | Burke Neutech, Inc. | 1995-10-19 |
| HAIR TRONICS MODEL HT8000 (K915845) | Global Tronics Intl., Inc. | 1992-07-29 |
| GUARANTY HAIR REMOVAL SYSTEM (K905125) | Stephens Mfg. Co. | 1991-08-05 |
| AHRS EPILATOR 629 (K892514) | American Hair Removal System Co. | 1990-08-14 |
| EPILATOR 8500 (K851413) | Lois Yee Cosmetics, Inc. | 1985-06-10 |
| NEMDI (K843734) | Nemectron Medical, Inc. | 1984-10-25 |
| SOFTEPIL (K843735) | Nemectron Medical, Inc. | 1984-10-25 |
| DEPILATOR, DERMA-I & DERMA-II (K770791) | Electro-Kinetic Eng/Mfg | 1981-01-26 |
| DPA 207 PERSONAL (K802513) | Hill, Farrer & Borrill | 1980-12-16 |
| DEBUTRON (K782119) | Martin Electric Co. | 1979-02-26 |
| EPILATION TYPE DEVICE (K780348) | Mehl, Thomas L. | 1978-05-18 |
| DEPILATORY, ELECTRONIC (K772322) | Dura Corp., The | 1978-01-03 |
| ELECTRONIC EIPLATOR MODEL NO. 101 (K771575) | Electronic Depilatory, Inc. | 1977-09-06 |
| ELECTRONIC DEPILATORY MODEL 303 (K770187) | Electronic Depilatory, Inc. | 1977-02-23 |
| ELECTRONIC DEPILATORY MODEL 202 (K770186) | Electronic Depilatory, Inc. | 1977-02-23 |
| KENATRON EPILATOR (K761049) | Epilator Corp. | 1977-01-05 |
| ELECTROLYSIS MACHINE (PERMATRON) (K760423) | Epco Hair Removal Corp. | 1976-09-15 |
Track KCX automatically
Every clearance here is in the API, with alerts when new ones post.