K882372 is an FDA 510(k) clearance for the RESUBMITTED DIODE LASER COAGULATOR. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on August 2, 1988, 68 days after receiving the submission on May 26, 1988.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K882372 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1988 |
| Decision Date | August 02, 1988 |
| Days to Decision | 68 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 |