K141954 is an FDA 510(k) clearance for the XCEL 455 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 October 15, 2014, 89 days after receiving the submission on July 18, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K141954 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2014 |
| Decision Date | October 15, 2014 |
| Days to Decision | 89 days |
| Submission Type | Special |
| 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 |