Cleared Traditional

K132667 - SYNERGY ODM
(FDA 510(k) Clearance)

K132667 · Topcon Medical Systems, Inc. · Ophthalmic device

Oct 2013

Decision

43d

Days

Class 2

Risk

K132667 is an FDA 510(k) clearance for the SYNERGY ODM. This device is classified as a System, Image Management, Ophthalmic (Class II - Special Controls, product code NFJ).

Submitted by Topcon Medical Systems, Inc. (North Reading, US). The FDA issued a Cleared decision on October 9, 2013, 43 days after receiving the submission on August 27, 2013.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K132667 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 27, 2013
Decision Date	October 09, 2013
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF