K061330 is an FDA 510(k) clearance for the PSL PORTABLE 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 May 25, 2006, 13 days after receiving the submission on May 12, 2006.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K061330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2006 |
| Decision Date | May 25, 2006 |
| Days to Decision | 13 days |
| Submission Type | Abbreviated |
| 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 |