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

Laser Assisted Lipolysis

21 CFR 878.4810 / General, Plastic Surgery
FDA source (opens on fda.gov)

ORK is the FDA product code for Laser Assisted Lipolysis, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "Intended to be used for laser assisted lipolysis". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
ORK
Device name
Laser Assisted Lipolysis
FDA definition
Intended to be used for laser assisted lipolysis
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code ORK

By decision year
1 clearance under product code ORK with a decision year between 2011 and 2011, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ORK by decision year
YearClearances
20111

Applicants with the most clearances

Product code ORK
Applicants holding the most 510(k) clearances under product code ORK
ApplicantClearances
Osyris Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code