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510(k) K101510

FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR by Endymed Medical, Ltd. — Product Code OUH

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