FDA product code ORK: Laser Assisted Lipolysis
ORK is the FDA product code for laser assisted lipolysis. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under ORK. The average 510(k) review took 672 days (median 672).
Definition
Intended to be used for laser assisted lipolysis
Classification
| Field | Value |
|---|---|
| Device name | Laser Assisted Lipolysis |
| 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) |
Compare with all 510(k) review times · Search every ORK clearance
Top ORK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osyris Medical | 1 | 2011-01-21 |
Most recent ORK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090754 | Osyris Medical | LIPOCONTROL | 2011-01-21 | 672 |
Recalls for ORK devices
openFDA lists no recalls for product code ORK.
Frequently asked questions
What is FDA product code ORK?
ORK is the FDA product code for laser assisted lipolysis. 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 ORK?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code ORK?
Across 1 cleared submissions the average was 672 days from receipt to decision (median 672).
Which companies have the most ORK clearances?
Osyris Medical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ORK
- Run a recall and safety report across every ORK manufacturer
- Watch product code ORK 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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