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510(k) K120513

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

K120513 is an FDA 510(k) premarket notification submitted by Endymed Medical, Ltd. for the device "GLOW BY ENDYMED". The FDA issued a decision of Substantially Equivalent on May 8, 2012. 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
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

Other clearances by Endymed Medical, Ltd.

  • K242996 — EndyMed PRO MAX (June 10, 2025)
  • K222369 — PURE Laser (October 7, 2022)
  • K161715 — EndyGel (February 7, 2017)
  • K161199 — EndyMed Contour Handpiece (August 1, 2016)
  • DEN150005 — Newa Skin Therapy System (December 18, 2015)
  • K130501 — INTENSIF (March 13, 2014)
  • K101510 — FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR (February 17, 2011)

Other clearances for product code OUH

  • K150409 — VIVACE Electrosurgical System (January 15, 2016)
  • K142833 — INTRAGen (June 4, 2015)
  • K130501 — INTENSIF (March 13, 2014)
  • K101510 — FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR (February 17, 2011)

FDA data resources