K862987 is an FDA 510(k) clearance for the MODEL 1000 OPHTHALMIC LASER SYSTEM. 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 September 24, 1986, 48 days after receiving the submission on August 7, 1986.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K862987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1986 |
| Decision Date | September 24, 1986 |
| Days to Decision | 48 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 |