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

Laser, Cellulite Appearance

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

OYW is the FDA product code for Laser, Cellulite Appearance, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "For the removal of fat through laser lipolysis". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OYW
Device name
Laser, Cellulite Appearance
FDA definition
For the removal of fat through laser 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
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code OYW

By decision year
2 clearances under product code OYW with a decision year between 2012 and 2013, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OYW by decision year
YearClearances
20121
20131

Applicants with the most clearances

Product code OYW
Applicants holding the most 510(k) clearances under product code OYW
ApplicantClearances
Cynosure, LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code