Product code KCX
- Device name
- Epilator, High Frequency, Tweezer-Type
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.5360
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973773 | DAPELLE HAIR REMOVER | Wellquest Intl., Inc. | 1997-12-17 |
| K973340 | TWEEZER-TYPE EPILATOR | Mobit, Inc. | 1997-12-03 |
| K973179 | FEMINIQUE SONIC HAIR REMOVER | Global TV Concepts, Ltd. | 1997-10-30 |
| K973174 | SONIQUE HAIR REMOVER | Global TV Concepts, Ltd. | 1997-10-30 |
| K972695 | FINALLY FREE | Mehl/Group Marketing | 1997-10-22 |
| K970338 | TWEEZER-TYPE EPILATOR | Igia Direct, Inc. | 1997-07-01 |
| K935706 | EPI 2 | Universal H.R. System, Inc. | 1997-02-11 |
| K943872 | COMMANDER MARK II HAIR REMOVAL SYSTEM | The Helene Edgar Corp. | 1995-10-26 |
| K952117 | EPILATOR | Burke Neutech, Inc. | 1995-10-19 |
| K915845 | HAIR TRONICS MODEL HT8000 | Global Tronics Intl., Inc. | 1992-07-29 |
| K905125 | GUARANTY HAIR REMOVAL SYSTEM | Stephens Mfg. Co. | 1991-08-05 |
| K892514 | AHRS EPILATOR 629 | American Hair Removal System Co. | 1990-08-14 |
| K851413 | EPILATOR 8500 | Lois Yee Cosmetics, Inc. | 1985-06-10 |
| K843735 | SOFTEPIL | Nemectron Medical, Inc. | 1984-10-25 |
| K843734 | NEMDI | Nemectron Medical, Inc. | 1984-10-25 |
| K770791 | DEPILATOR, DERMA-I & DERMA-II | Electro-Kinetic Eng/Mfg | 1981-01-26 |
| K802513 | DPA 207 PERSONAL | Hill, Farrer & Borrill | 1980-12-16 |
| K782119 | DEBUTRON | Martin Electric Co. | 1979-02-26 |
| K780348 | EPILATION TYPE DEVICE | Mehl, Thomas L. | 1978-05-18 |
| K772322 | DEPILATORY, ELECTRONIC | Dura Corp., The | 1978-01-03 |
| K771575 | ELECTRONIC EIPLATOR MODEL NO. 101 | Electronic Depilatory, Inc. | 1977-09-06 |
| K770187 | ELECTRONIC DEPILATORY MODEL 303 | Electronic Depilatory, Inc. | 1977-02-23 |
| K770186 | ELECTRONIC DEPILATORY MODEL 202 | Electronic Depilatory, Inc. | 1977-02-23 |
| K761049 | KENATRON EPILATOR | Epilator Corp. | 1977-01-05 |
| K760423 | ELECTROLYSIS MACHINE (PERMATRON) | Epco Hair Removal Corp. | 1976-09-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06974456210518 | CICADA | Foshan Cicada Dental Instrument Co., Ltd. | 2024-08-10 |
| G443CSC2311 | Bracket Tweezer with Slot | CHURAHI SURGICAL CO. | 2023-08-08 |
| G443CSC2321 | Bracket Tweezer Tube Holding | CHURAHI SURGICAL CO. | 2023-08-08 |
| G443CSC2331 | Bracket Tweezer small Point | CHURAHI SURGICAL CO. | 2023-08-08 |
| 00810072350831 | Tweezers | Cole Instruments Inc | 2021-12-14 |
| 00810042120464 | DENALI | ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC | 2020-04-21 |
| 00810042120471 | DENALI | ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC | 2020-04-21 |
| 00810042120488 | DENALI | ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC | 2020-04-21 |
| 00810042120235 | DENALI | ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC | 2020-04-21 |
| 00810042120242 | DENALI | ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC | 2020-04-21 |
| 00810042120259 | DENALI | ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC | 2020-04-21 |
| 00810042120266 | DENALI | ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC | 2020-04-21 |
| 00810042120273 | DENALI | ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC | 2020-04-21 |
| 07898961579146 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |