Cleared Traditional

K943125 - QUADRASPHERIC FUNDUS LENS

K943125 is an FDA 510(k) clearance for QUADRASPHERIC FUNDUS LENS, manufactured by Volk Optical, Inc.. The device is a Class 2 Ophthalmic device with product code HJK cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K943125 · Volk Optical, Inc. · Ophthalmic device
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Sep 1994
Decision
65d
Days
Class 2
Risk

K943125 is an FDA 510(k) clearance for the QUADRASPHERIC FUNDUS LENS. Classified as Lens, Contact, Polymethylmethacrylate, Diagnostic (product code HJK), Class II - Special Controls.

Submitted by Volk Optical, Inc. (Cleveland, US). The FDA issued a Cleared decision on September 2, 1994 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1385 - 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 Volk Optical, Inc. devices

FDA 510(k) Submission Details - K943125

510(k) Number K943125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1994
Decision Date September 02, 1994
Days to Decision 65 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
45d faster than avg
Panel avg: 110d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJK Device Classification - Class 2, Special Controls

Product Code HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1385
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 - HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

All 29
Devices cleared under the same product code (HJK) and FDA review panel - the closest regulatory comparables to K943125.
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