FINALLY FREE
FDA 510(k) clearance K972695 · decided 1997-10-22
Clearance details
- K-number
- K972695
- Device name
- FINALLY FREE
- Applicant
- Mehl/Group Marketing
- Decision
- Substantially Equivalent
- Date received
- 1997-07-18
- Decision date
- 1997-10-22
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- KCX
- Device class
- 1
- Regulation number
- 878.5360
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Budd Lake, NJ, 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 |
|---|---|---|
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.