K133132 is an FDA 510(k) clearance for the OPTICAL BIOMETER AL-SCAN. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).
Submitted by Nidek Co., Ltd. (Sunnyvale, US). The FDA issued a Cleared decision on June 11, 2014, 254 days after receiving the submission on September 30, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K133132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2013 |
| Decision Date | June 11, 2014 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HJO — Biomicroscope, Slit-lamp, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |