510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130501Substantially Equivalent

Intensif

Endymed Medical Inc., Binyamina, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130501 is the FDA 510(k) clearance record for INTENSIF, a class II device, cleared for Endymed Medical, Ltd. on under FDA product code OUH (Skin Resurfacing Rf Applicator). FDA's definition for product code OUH reads: "Skin resurfacing". FDA records list 8 510(k) clearances for Endymed Medical, Ltd., from to . As of , FDA records show no recalls naming K130501.

Clearance record

Decision date
Received
(379 days to decision)
Product code
OUH Skin Resurfacing Rf Applicator
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Endymed Medical, Ltd. Haavoda 31 St., Binyamina, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUH

Trailing 12 months

FDA records hold no clearances under product code OUH in the trailing twelve months.

FDA records show no clearances under product code OUH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260