Cleared Traditional

SCOPTOPIC SENSITIVITY TEST-1[SST-1]

K914163 · Lkc Technologies, Inc. · Ophthalmic
Oct 1991
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K914163 is an FDA 510(k) clearance for the SCOPTOPIC SENSITIVITY TEST-1[SST-1], a Photostimulator, Ac-powered (Class II — Special Controls, product code HLX), submitted by Lkc Technologies, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on October 25, 1991, 38 days after receiving the submission on September 17, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1630.

Submission Details

510(k) Number K914163 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 1991
Decision Date October 25, 1991
Days to Decision 38 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HLX — Photostimulator, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1630

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