Cleared Traditional

K914393 - RETINA TESTER

K914393 is an FDA 510(k) clearance for RETINA TESTER, manufactured by Retina Tester. The device is a Class 2 Ophthalmic device with product code HLX cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K914393 · Retina Tester · Ophthalmic device
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Mar 1992
Decision
153d
Days
Class 2
Risk

K914393 is an FDA 510(k) clearance for the RETINA TESTER. Classified as Photostimulator, Ac-powered (product code HLX), Class II - Special Controls.

Submitted by Retina Tester (Memphis, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Retina Tester devices

FDA 510(k) Submission Details - K914393

510(k) Number K914393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 110d · This submission: 153d
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 K914393.
EDI VERIS SYSTEM
K983983 · Electro-Diagnostic Imaging, Inc. · Feb 1999
CLARUS ENDOSCOPIC HOOK KNIFE
K925741 · Clarus Medical Systems, Inc. · Aug 1993
LED GOGGLES
K831231 · Cadwell Laboratories, Inc. · May 1983
CONTRAST SENSITIVITY EQUIPMENT
K830770 · Cadwell Laboratories, Inc. · Apr 1983
5031 BRIGHT FLASH STIMULATOR
K822915 · Life-Tech Intl., Inc. · Dec 1982
5010 VISUSTIM
K822919 · Life-Tech Intl., Inc. · Dec 1982