Product code KCW
- Device name
- Epilator, High Frequency, Needle-Type
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.5350
- 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 |
|---|---|---|---|
| K954031 | COMPU-BLEND EPILATOR | R. A. Fischer Co. Corp. | 1996-01-05 |
| K952611 | STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION | Sterex Electrolysis Intl., Ltd. | 1995-10-18 |
| K945192 | HAIR REMOVAL SYSTEM | L.P. Systems Corp. | 1995-01-12 |
| K943928 | APILUS ELECTROPIL | Dectro Intl., Inc. | 1995-01-12 |
| K943399 | THE SS-99 | Instantron | 1994-09-16 |
| K943398 | THE BLENDTONE ROYALE | Instantron | 1994-09-16 |
| K943396 | THE ELITE SPECTRUM | Instantron | 1994-09-16 |
| K941227 | SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL | Instantron | 1994-08-18 |
| K931062 | THE VP500 EPILATOR | Instantron | 1993-07-08 |
| K931063 | THE ELITE EPILATOR | Instantron | 1993-07-08 |
| K931064 | THE BLENDTONE EPILATOR | Instantron | 1993-07-08 |
| K911983 | WIZARD STERILIZED ELECTROEPILATION NEEDLE | Skin Deep, Inc. | 1991-10-15 |
| K904015 | ELECTRO-BLEND EPILATOR, MODEL UC-3 | A.R. Hinkel Co., Inc. | 1990-10-04 |
| K895687 | D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE) | Carol Block, Ltd. | 1990-08-09 |
| K894771 | EPILATION NEEDLE | Precision Electrolysis Needles, Inc. | 1989-08-21 |
| K893389 | MODEL SE-5 EPILATOR | R. A. Fischer Co. Corp. | 1989-06-05 |
| K883892 | BALLET STERILE DISPOSABLE ELECTROLYSIS | Synoptic Products | 1988-10-20 |
| K884079 | MODEL CBX EPILATOR | R. A. Fischer Co. Corp. | 1988-10-04 |
| K883429 | LINDSTROM CORDLESS EPILATOR | A Place of Health & Beauty | 1988-09-28 |
| K881276 | HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS | Ime Co. , Ltd. | 1988-05-04 |
| K880553 | ELECTRONIC EPILATOR | Clareblend, Inc. | 1988-02-29 |
| K874891 | FLEXIE THE COPPER SHANK NEEDLE | Skin Deep, Inc. | 1988-01-07 |
| K864869 | HR-5000 ELECTROSURGICAL DEVICE | Ime Co. , Ltd. | 1987-05-19 |
| K871372 | CB-7 ELECTRONIC EPILATOR | R. A. Fischer Co. Corp. | 1987-04-28 |
| K864291 | HIGH FREQUENCY NEEDLE-TYPE EPILATOR | Multi-Channel Epilator | 1986-12-24 |
| K864289 | MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR | Alexander Thomas, Inc. | 1986-12-01 |
| K860056 | BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR) | Berkowits School of Electrolysis, Inc. | 1986-02-05 |
| K851318 | GUIBOR MICROELECTROLYSIS UNIT 18 | Galvanic Medical Instruments, Inc. | 1985-08-20 |
| K843063 | ELECTRONIC EPILATOR TS-1 | R. A. Fischer Co. Corp. | 1984-09-26 |
| K834572 | EPITRON SUPER | Leo Unlimited, Inc. | 1984-04-23 |
Related GUDID Devices#
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|---|---|---|---|
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| 00667259003963 | EVOLUTION XHD | Silhouet-Tone Corporation | 2025-07-09 |
| 00667259003970 | EVOLUTION ST350 | Silhouet-Tone Corporation | 2025-07-09 |
| 08800016903317 | Secret RF Smartcure Applicator With Electrodes | CLASSYS Inc. | 2024-10-30 |
| 00686209052028 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209052158 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209052141 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209052134 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209052127 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209052110 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209052059 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209052042 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209052035 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209052011 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209051052 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209051045 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209051038 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209051021 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209051014 | Pro-Tec | Dectro International | 2024-10-09 |
| 00686209100903 | Apilus | Dectro International | 2024-05-23 |
| 00686209100910 | Apilus | Dectro International | 2024-05-23 |
| 00686209101115 | Apilus | Dectro International | 2024-05-23 |
| 00686209106004 | Apilus | Dectro International | 2024-05-23 |
| 00686209106059 | Apilus | Dectro International | 2024-05-23 |
| 00686209101238 | Apilus | Dectro International | 2024-05-22 |
| 00850057194036 | Elegance | Clareblend, Inc. | 2023-12-14 |
| 00850057194005 | Elegance+ | Clareblend, Inc. | 2023-12-14 |
| 18800067700016 | AGNES-S | AGNES MEDICAL CO., LTD. | 2023-07-14 |
| 18800067700009 | AGNES | AGNES MEDICAL CO., LTD. | 2023-07-14 |
| 08800067700002 | AGNES | AGNES MEDICAL CO., LTD. | 2023-07-14 |