K133217 is an FDA 510(k) clearance for the CIRRUS PHOTO. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Carl Zeiss Meditec, AG (Dublin, US). The FDA issued a Cleared decision on March 19, 2014, 152 days after receiving the submission on October 18, 2013.
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 | K133217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2013 |
| Decision Date | March 19, 2014 |
| Days to Decision | 152 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. |