K131567 is an FDA 510(k) clearance for the ALADDIN. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).
Submitted by Visia Imaging S.R.L. (Ormond Beach, US). The FDA issued a Cleared decision on June 5, 2014, 371 days after receiving the submission on May 30, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K131567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2013 |
| Decision Date | June 05, 2014 |
| Days to Decision | 371 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 |