KCW — Epilator, High Frequency, Needle-Type Class I
FDA product code KCW covers "Epilator, High Frequency, Needle-Type", a Class I medical device regulated under 21 CFR 878.5350. 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
- KCW
- Device Class
- Class I
- Regulation Number
- 878.5350
- Submission Type
- 510(k) Exempt
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K954031 | R. A. Fischer Co | COMPU-BLEND EPILATOR | Jan 5, 1996 |
| K952611 | Sterex Electrolysis Intl | STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION | Oct 18, 1995 |
| K945192 | L.P. Systems | HAIR REMOVAL SYSTEM | Jan 12, 1995 |
| K943928 | Dectro Intl | APILUS ELECTROPIL | Jan 12, 1995 |
| K943398 | Instantron | THE BLENDTONE ROYALE | Sep 16, 1994 |
| K943399 | Instantron | THE SS-99 | Sep 16, 1994 |
| K943396 | Instantron | THE ELITE SPECTRUM | Sep 16, 1994 |
| K941227 | Instantron | SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL | Aug 18, 1994 |
| K931062 | Instantron | THE VP500 EPILATOR | Jul 8, 1993 |
| K931064 | Instantron | THE BLENDTONE EPILATOR | Jul 8, 1993 |
| K931063 | Instantron | THE ELITE EPILATOR | Jul 8, 1993 |
| K911983 | Skin Deep | WIZARD STERILIZED ELECTROEPILATION NEEDLE | Oct 15, 1991 |
| K904015 | A.R. Hinkel Co | ELECTRO-BLEND EPILATOR, MODEL UC-3 | Oct 4, 1990 |
| K895687 | Carol Block | D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE) | Aug 9, 1990 |
| K894771 | Precision Electrolysis Needles | EPILATION NEEDLE | Aug 21, 1989 |
| K893389 | R. A. Fischer Co | MODEL SE-5 EPILATOR | Jun 5, 1989 |
| K883892 | Synoptic Products | BALLET STERILE DISPOSABLE ELECTROLYSIS | Oct 20, 1988 |
| K884079 | R. A. Fischer Co | MODEL CBX EPILATOR | Oct 4, 1988 |
| K883429 | A Place Of Health And Beauty | LINDSTROM CORDLESS EPILATOR | Sep 28, 1988 |
| K881276 | Ime Co. | HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS | May 4, 1988 |