Cleared Traditional

OPHTHALMIC TRIAL LENSES (K930195) - FDA 510(k) Clearance

Class I Ophthalmic device.

K930195 · Optimark Accessories and Instruments · Ophthalmic device
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Jan 1994
Decision
357d
Days
Class 1
Risk

K930195 is an FDA 510(k) clearance for the OPHTHALMIC TRIAL LENSES. Classified as Set, Lens, Trial, Ophthalmic (product code HPC), Class I - General Controls.

Submitted by Optimark Accessories and Instruments (Seattle, US). The FDA issued a Cleared decision on January 6, 1994 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1405 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K930195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date January 06, 1994
Days to Decision 357 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
247d slower than avg
Panel avg: 110d · This submission: 357d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPC Set, Lens, Trial, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1405
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.