FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
FDA 510(k) clearance K101510 · decided 2011-02-17
Clearance details
- K-number
- K101510
- Device name
- FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
- Applicant
- Endymed Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-01
- Decision date
- 2011-02-17
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- OUH
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Binyamina, IL
- 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 |
|---|---|---|
| VIVACE Electrosurgical System (K150409) | Sung Hwan E&B Co.,Ltd | 2016-01-15 |
| INTRAGen (K142833) | Jeisys Medical, Inc. | 2015-06-04 |
| INTENSIF (K130501) | Endymed Medical, Ltd. | 2014-03-13 |
| GLOW BY ENDYMED (K120513) | Endymed Medical, Ltd. | 2012-05-08 |
Recalls involving this device
No recalls on record reference this clearance.