Cleared Traditional

ALADDIN

K131567 · Visia Imaging S.R.L. · Ophthalmic

Jun 2014

Decision

371d

Days

Class 2

Risk

About This 510(k) Submission

K131567 is an FDA 510(k) clearance for the ALADDIN, 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 review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K131567 FDA.gov
FDA Decision	Cleared 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