K854949 is an FDA 510(k) clearance for the MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by CooperVision, Inc. (Santa Clara, US). The FDA issued a Cleared decision on February 4, 1986, 56 days after receiving the submission on December 10, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K854949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 1985 |
| Decision Date | February 04, 1986 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQF — Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |