K121622 is an FDA 510(k) clearance for the NIDEK RS-3000. 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 March 14, 2013, 286 days after receiving the submission on June 1, 2012.
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 | K121622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2012 |
| Decision Date | March 14, 2013 |
| Days to Decision | 286 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. |