The following data is part of a premarket notification filed by Od -os Gmbh with the FDA for Navilas Laser System.
| Device ID | K091064 |
| 510k Number | K091064 |
| Device Name: | NAVILAS LASER SYSTEM |
| Classification | Laser, Ophthalmic |
| Applicant | OD -OS GMBH 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Contact | Judy Gordon |
| Correspondent | Judy Gordon OD -OS GMBH 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2009-10-27 |
| Summary: | summary |