K132323 is an FDA 510(k) clearance for the RS-3000 ADVANCE. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Nidek Co., Ltd. (Wadsworth, US). The FDA issued a Cleared decision on February 19, 2014, 209 days after receiving the submission on July 25, 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 | K132323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2013 |
| Decision Date | February 19, 2014 |
| Days to Decision | 209 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. |