K111505 is an FDA 510(k) clearance for the RTVUE CAM WITH CORNEAL POWER UPGRADE. 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 September 8, 2011, 100 days after receiving the submission on May 31, 2011.
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 | K111505 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2011 |
| Decision Date | September 08, 2011 |
| Days to Decision | 100 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. |