510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090754Substantially Equivalent

Lipocontrol

Osyris Medical, France, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090754 is the FDA 510(k) clearance record for LIPOCONTROL, a class II device, cleared for Osyris Medical on under FDA product code ORK (Laser Assisted Lipolysis). FDA's definition for product code ORK reads: "Intended to be used for laser assisted lipolysis". FDA records list one 510(k) clearance for Osyris Medical. As of , FDA records show no recalls naming K090754.

Clearance record

Decision date
Received
(672 days to decision)
Product code
ORK Laser Assisted Lipolysis
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Osyris Medical 60 Ave. Halley, France, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ORK

Trailing 12 months

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

FDA records show no clearances under product code ORK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ORK, 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