K143275 is an FDA 510(k) clearance for the IOLMaster700. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).
Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on July 10, 2015, 238 days after receiving the submission on November 14, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K143275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2014 |
| Decision Date | July 10, 2015 |
| Days to Decision | 238 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 |