K091064 is an FDA 510(k) clearance for the NAVILAS LASER SYSTEM. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Od-Os GmbH (Laguna Beach, US). The FDA issued a Cleared decision on October 27, 2009, 196 days after receiving the submission on April 14, 2009.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K091064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2009 |
| Decision Date | October 27, 2009 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |