K142953 is an FDA 510(k) clearance for the OCT-Camera. This device is classified as a Ophthalmoscope, Ac-powered (Class II - Special Controls, product code HLI).
Submitted by Optomedical Technologies GmbH (Luebeck, DE). The FDA issued a Cleared decision on March 4, 2015, 145 days after receiving the submission on October 10, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K142953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2014 |
| Decision Date | March 04, 2015 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HLI - Ophthalmoscope, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |