Cleared Traditional

ALADDIN HW3.0

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

Oct 2016

Decision

243d

Days

Class 2

Risk

About This 510(k) Submission

K160327 is an FDA 510(k) clearance for the ALADDIN HW3.0, 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 review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K160327 FDA.gov
FDA Decision	Cleared 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