K850270 is an FDA 510(k) clearance for the CORNEAL LIGHT SHIELD. This device is classified as a Microscope, Operating & Accessories, Ac-powered, Ophthalmic (Class I - General Controls, product code HRM).
Submitted by Mentor O & O, Inc. (Hingham, US). The FDA issued a Cleared decision on May 31, 1985, 128 days after receiving the submission on January 23, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4700.
| 510(k) Number | K850270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1985 |
| Decision Date | May 31, 1985 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HRM — Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4700 |