K133892 is an FDA 510(k) clearance for the IVUE 500. This device is classified as a Ophthalmoscope, Ac-powered (Class II - Special Controls, product code HLI).
Submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on March 19, 2014, 89 days after receiving the submission on December 20, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K133892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2013 |
| Decision Date | March 19, 2014 |
| Days to Decision | 89 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 |