K091404 is an FDA 510(k) clearance for the IVUE, MODEL 100. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on April 22, 2010, 345 days after receiving the submission on May 12, 2009.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570. Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases..
| 510(k) Number | K091404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2009 |
| Decision Date | April 22, 2010 |
| Days to Decision | 345 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OBO - Tomography, Optical Coherence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |
| Definition | Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases. |