ORK — Laser Assisted Lipolysis Class II
FDA product code ORK covers "Laser Assisted Lipolysis", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- ORK
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Intended to be used for laser assisted lipolysis
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K090754 | osyris medical | LIPOCONTROL | January 21, 2011 |