Cleared Traditional

K914163 - SCOPTOPIC SENSITIVITY TEST-1[SST-1]

K914163 is an FDA 510(k) clearance for SCOPTOPIC SENSITIVITY TEST-1[SST-1], manufactured by Lkc Technologies, Inc.. The device is a Class 2 Ophthalmic device with product code HLX cleared through the Traditional 510(k) pathway after a 38-day FDA review.

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

K914163 is an FDA 510(k) clearance for the SCOPTOPIC SENSITIVITY TEST-1[SST-1]. Classified as Photostimulator, Ac-powered (product code HLX), Class II - Special Controls.

Submitted by Lkc Technologies, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on October 25, 1991 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1630 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lkc Technologies, Inc. devices

FDA 510(k) Submission Details - K914163

510(k) Number K914163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 110d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLX Device Classification - Class 2, Special Controls

Product Code HLX Photostimulator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HLX Photostimulator, Ac-powered

All 9
Devices cleared under the same product code (HLX) and FDA review panel - the closest regulatory comparables to K914163.
EDI VERIS SYSTEM
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K822915 · Life-Tech Intl., Inc. · Dec 1982
5010 VISUSTIM
K822919 · Life-Tech Intl., Inc. · Dec 1982