The following data is part of a premarket notification filed by Nidek Co., Ltd. with the FDA for Optical Biometer Al-scan.
| Device ID | K133132 |
| 510k Number | K133132 |
| Device Name: | OPTICAL BIOMETER AL-SCAN |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | NIDEK CO., LTD. 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale, CA 94085 |
| Contact | Darlene Crockett-billig |
| Correspondent | Darlene Crockett-billig NIDEK CO., LTD. 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale, CA 94085 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-06-11 |
| Summary: | summary |