Cleared Traditional

RETINA TESTER

K914393 · Retina Tester · Ophthalmic

Mar 1992

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K914393 is an FDA 510(k) clearance for the RETINA TESTER, a Photostimulator, Ac-powered (Class II — Special Controls, product code HLX), submitted by Retina Tester (Memphis, US). The FDA issued a Cleared decision on March 2, 1992, 153 days after receiving the submission on October 1, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1630.

Submission Details

510(k) Number	K914393 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 1991
Decision Date	March 02, 1992
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement