K222166 is an FDA 510(k) clearance for the SOLIX. 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 November 9, 2022, 111 days after receiving the submission on July 21, 2022.
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 | K222166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2022 |
| Decision Date | November 09, 2022 |
| Days to Decision | 111 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. |