K182306 is an FDA 510(k) clearance for the Sunkingdom Slit Lamp. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).
Submitted by Chongqing Sunkingdom Medical Instrument Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on November 22, 2018, 90 days after receiving the submission on August 24, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K182306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2018 |
| Decision Date | November 22, 2018 |
| Days to Decision | 90 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 |