INTENSIF— 510(k) K130501

Substantially Equivalent

Endymed Medical, Ltd.

FDA 510(k) clearance K130501 for INTENSIF, Substantially Equivalent on 2014-03-13. Applicant: Endymed Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Endymed Medical, Ltd.
Product code: Code OUH
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2013-02-27
Decision date: 2014-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUH

K150409 — VIVACE Electrosurgical System2016-01-15
K142833 — INTRAGen2015-06-04
K120513 — GLOW BY ENDYMED2012-05-08
K101510 — FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR2011-02-17

More clearances from Endymed Medical, Ltd.

K242996 — EndyMed PRO MAX2025-06-10
K222369 — PURE Laser2022-10-07
K161715 — EndyGel2017-02-07
K161199 — EndyMed Contour Handpiece2016-08-01
DEN150005 — Newa Skin Therapy System2015-12-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.