The following data is part of a premarket notification filed by Osyris Medical with the FDA for Lipocontrol.
| Device ID | K090754 |
| 510k Number | K090754 |
| Device Name: | LIPOCONTROL |
| Classification | Laser Assisted Lipolysis |
| Applicant | OSYRIS MEDICAL 60 AVENUE HALLEY F59650 VILLENEUVE D'ASQ France, FR F59650 |
| Contact | Blandine Bouvet |
| Correspondent | Blandine Bouvet OSYRIS MEDICAL 60 AVENUE HALLEY F59650 VILLENEUVE D'ASQ France, FR F59650 |
| Product Code | ORK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-20 |
| Decision Date | 2011-01-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LIPOCONTROL 77620890 3691621 Dead/Cancelled |
LSO MEDICAL 2008-11-24 |