The following data is part of a premarket notification filed by Oculight Ltd. with the FDA for Nam Illumination Probe With Chopper.
| Device ID | K202670 |
| 510k Number | K202670 |
| Device Name: | Nam Illumination Probe With Chopper |
| Classification | Endoilluminator |
| Applicant | Oculight Ltd. Seongnamdaelo 1342, B111 Seongnam-si, KR 13120 |
| Contact | Jinman Kim |
| Correspondent | Robert Packard Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, VT 05738 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2021-08-20 |