K081946 is an FDA 510(k) clearance for the SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Quantel Medical (Hasbrouck Heights, US). The FDA issued a Cleared decision on March 25, 2009, 260 days after receiving the submission on July 8, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K081946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2008 |
| Decision Date | March 25, 2009 |
| Days to Decision | 260 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF — Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |