K140336 is an FDA 510(k) clearance for the OPTIMUS FUSION: SLT, YAG AND YAG/SLT. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Quantel Medical (North Reading, US). The FDA issued a Cleared decision on June 25, 2014, 135 days after receiving the submission on February 10, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K140336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2014 |
| Decision Date | June 25, 2014 |
| Days to Decision | 135 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 |