Cleared Traditional

K790526 - LIO-714 OPACITYMETER (FDA 510(k) Clearance)

Class I Ophthalmic device.

K790526 · Laser Industries , Ltd. · Ophthalmic device
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Nov 1979
Decision
246d
Days
Class 1
Risk

K790526 is an FDA 510(k) clearance for the LIO-714 OPACITYMETER. Classified as Lens, Condensing, Diagnostic (product code HJL), Class I - General Controls.

Submitted by Laser Industries , Ltd. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1979 after a review of 246 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1380 - 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 Laser Industries , Ltd. devices

Submission Details

510(k) Number K790526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1979
Decision Date November 16, 1979
Days to Decision 246 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 110d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJL Lens, Condensing, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1380
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.