K122418 is an FDA 510(k) clearance for the IOLMASTER 500. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).
Submitted by Carl Zeiss Meditec, AG (Dublin, US). The FDA issued a Cleared decision on April 12, 2013, 247 days after receiving the submission on August 8, 2012.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K122418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2012 |
| Decision Date | April 12, 2013 |
| Days to Decision | 247 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 |