The following data is part of a premarket notification filed by Od -os Gmbh with the FDA for Navilas Laser System.
| Device ID | K141851 |
| 510k Number | K141851 |
| Device Name: | NAVILAS LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OD -OS GMBH 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon OD -OS GMBH 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-09 |
| Decision Date | 2015-01-02 |
| Summary: | summary |