510(k) K101510
K101510 is an FDA 510(k) premarket notification submitted by Endymed Medical, Ltd. for the device "FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR". The FDA issued a decision of Substantially Equivalent on February 17, 2011. The device falls under product code OUH (Skin Resurfacing Rf Applicator), a Class II device regulated under 21 CFR 878.4400. Endymed Medical, Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2011
- Date Received
- June 1, 2010
- 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