EPILATRON
FDA 510(k) clearance K810843 · decided 1981-05-08
Clearance details
- K-number
- K810843
- Device name
- EPILATRON
- Applicant
- Electrola
- Decision
- Substantially Equivalent
- Date received
- 1981-03-27
- Decision date
- 1981-05-08
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- KCW
- Device class
- 1
- Regulation number
- 878.5350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COMPU-BLEND EPILATOR (K954031) | R. A. Fischer Co. Corp. | 1996-01-05 |
| STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION (K952611) | Sterex Electrolysis Intl., Ltd. | 1995-10-18 |
| HAIR REMOVAL SYSTEM (K945192) | L.P. Systems Corp. | 1995-01-12 |
| APILUS ELECTROPIL (K943928) | Dectro Intl., Inc. | 1995-01-12 |
| THE BLENDTONE ROYALE (K943398) | Instantron | 1994-09-16 |
| THE ELITE SPECTRUM (K943396) | Instantron | 1994-09-16 |
| THE SS-99 (K943399) | Instantron | 1994-09-16 |
| SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL (K941227) | Instantron | 1994-08-18 |
| THE VP500 EPILATOR (K931062) | Instantron | 1993-07-08 |
| THE ELITE EPILATOR (K931063) | Instantron | 1993-07-08 |
| THE BLENDTONE EPILATOR (K931064) | Instantron | 1993-07-08 |
| WIZARD STERILIZED ELECTROEPILATION NEEDLE (K911983) | Skin Deep, Inc. | 1991-10-15 |
Recalls involving this device
No recalls on record reference this clearance.