510(k) K142833
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2015
- Date Received
- September 30, 2014
- 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