VIVACE Electrosurgical System
FDA 510(k) clearance K150409 · decided 2016-01-15
Clearance details
- K-number
- K150409
- Device name
- VIVACE Electrosurgical System
- Applicant
- Sung Hwan E&B Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2015-02-18
- Decision date
- 2016-01-15
- Days to decision
- 331 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
- Seongdong-Gu, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sung Hwan E&B Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR (K101510) | Endymed Medical, Ltd. | 2011-02-17 |
Recalls involving this device
No recalls on record reference this clearance.