K222372 is an FDA 510(k) clearance for the Kowa SL-19. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).
Submitted by Kowa Company , Ltd. (Chofu-Shi, JP). The FDA issued a Cleared decision on November 21, 2022, 108 days after receiving the submission on August 5, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K222372 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2022 |
| Decision Date | November 21, 2022 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HJO - Biomicroscope, Slit-lamp, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |