Cleared Traditional

OCT-Camera

K142953 · Optomedical Technologies GmbH · Ophthalmic

Mar 2015

Decision

145d

Days

Class 2

Risk

About This 510(k) Submission

K142953 is an FDA 510(k) clearance for the OCT-Camera, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Optomedical Technologies GmbH (Luebeck, DE). The FDA issued a Cleared decision on March 4, 2015, 145 days after receiving the submission on October 10, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K142953 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 2014
Decision Date	March 04, 2015
Days to Decision	145 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF