FDA product code OYW: Laser, Cellulite Appearance
OYW is the FDA product code for laser, cellulite appearance. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under OYW. The average 510(k) review took 327 days (median 327).
Definition
For the removal of fat through laser lipolysis.
Classification
| Field | Value |
|---|---|
| Device name | Laser, Cellulite Appearance |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OYW clearance
Top OYW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cynosure, Inc. | 2 | 2013-03-29 |
Most recent OYW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123407 | Cynosure, Inc. | CELLULAZE LASER | 2013-03-29 | 144 |
| K102541 | Cynosure, Inc. | CYNOSURE CELLULAZE LASER | 2012-01-26 | 510 |
Recalls for OYW devices
openFDA lists no recalls for product code OYW.
Frequently asked questions
What is FDA product code OYW?
OYW is the FDA product code for laser, cellulite appearance. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel.
What device class is OYW?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code OYW?
Across 2 cleared submissions the average was 327 days from receipt to decision (median 327).
Which companies have the most OYW clearances?
Cynosure, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code OYW
- Run a recall and safety report across every OYW manufacturer
- Watch product code OYW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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