K163564 is an FDA 510(k) clearance for the SLIT LAMP SL-2000. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).
Submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on May 19, 2017, 151 days after receiving the submission on December 19, 2016.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K163564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2016 |
| Decision Date | May 19, 2017 |
| Days to Decision | 151 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 |