K180229 is an FDA 510(k) clearance for the RESCAN 700, CALLISTO eye. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on January 11, 2019, 350 days after receiving the submission on January 26, 2018.
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 | K180229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2018 |
| Decision Date | January 11, 2019 |
| Days to Decision | 350 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. |