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510(k) K130501

INTENSIF by Endymed Medical, Ltd. — Product Code OUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2014
Date Received
February 27, 2013
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)
  • K120513 — GLOW BY ENDYMED (May 8, 2012)
  • 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)
  • K120513 — GLOW BY ENDYMED (May 8, 2012)
  • K101510 — FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR (February 17, 2011)