Cleared Traditional

K160327 - ALADDIN HW3.0 (FDA 510(k) Clearance)

K160327 · Visia Imaging S.R.L. · Ophthalmic device

Oct 2016

Decision

243d

Days

Class 2

Risk

K160327 is an FDA 510(k) clearance for the ALADDIN HW3.0. 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. (San Giovanni Valdarno, IT). The FDA issued a Cleared decision on October 5, 2016, 243 days after receiving the submission on February 5, 2016.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K160327 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 05, 2016
Decision Date	October 05, 2016
Days to Decision	243 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement