Home / 510(k) Clearances / K120513

510(k) K120513

GLOW BY ENDYMED by Endymed Medical, Ltd. — Product Code OUH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 8, 2012
Date Received: February 21, 2012
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