The following data is part of a premarket notification filed by Od-os Gmbh with the FDA for Navilas Laser System.
| Device ID | K162191 |
| 510k Number | K162191 |
| Device Name: | NAVILAS Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OD-OS GMBH 14513 WARTHESTR. 21 Teltow, DE 14513 |
| Contact | Winfried Teiwes |
| Correspondent | Judy F. Gordon CLINREG CONSULTING SERVICES, INC. 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Product Code | GEX |
| Subsequent Product Code | HKI |
| Subsequent Product Code | NFF |
| Subsequent Product Code | NFG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-04 |
| Decision Date | 2016-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260284390013 | K162191 | 000 |