K854288 is an FDA 510(k) clearance for the OPHALMIC LASER PHOTOCOAGULATOR. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on November 12, 1985, 18 days after receiving the submission on October 25, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K854288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1985 |
| Decision Date | November 12, 1985 |
| Days to Decision | 18 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 |