K121739 is an FDA 510(k) clearance for the IVUE WITH NORMATIVE DATABASE. 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 January 18, 2013, 219 days after receiving the submission on June 13, 2012.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K121739 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2012 |
| Decision Date | January 18, 2013 |
| Days to Decision | 219 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 |