K202670 is an FDA 510(k) clearance for the Nam illumination probe with chopper. This device is classified as a Endoilluminator (Class II - Special Controls, product code MPA).
Submitted by Oculight , Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on August 20, 2021, 340 days after receiving the submission on September 14, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K202670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2020 |
| Decision Date | August 20, 2021 |
| Days to Decision | 340 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MPA - Endoilluminator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |