K063750 is an FDA 510(k) clearance for the XCEL 255 SLIT LAMP. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).
Submitted by Reichert, Inc. (Depew, US). The FDA issued a Cleared decision on December 20, 2006, 1 day after receiving the submission on December 19, 2006.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K063750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2006 |
| Decision Date | December 20, 2006 |
| Days to Decision | 1 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HJO - Biomicroscope, Slit-lamp, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |