K870839 is an FDA 510(k) clearance for the MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC. This device is classified as a Laser, Ophthalmic (Class II — Special Controls, product code HQF).
Submitted by Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on May 22, 1987, 86 days after receiving the submission on February 25, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K870839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1987 |
| Decision Date | May 22, 1987 |
| Days to Decision | 86 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 |