510(k) K150409
K150409 is an FDA 510(k) premarket notification submitted by Sung Hwan E&B Co.,Ltd for the device "VIVACE Electrosurgical System". The FDA issued a decision of Substantially Equivalent on January 15, 2016. The device falls under product code OUH (Skin Resurfacing Rf Applicator), a Class II device regulated under 21 CFR 878.4400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2016
- Date Received
- February 18, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Skin Resurfacing Rf Applicator
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Skin resurfacing