K791659 is an FDA 510(k) clearance for the MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Coburn Optical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 11, 1979, 50 days after receiving the submission on August 22, 1979.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K791659 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1979 |
| Decision Date | October 11, 1979 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | HQF — Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |