Cleared Traditional

MENTOR HORIZON LOW VISION MAGNIFIER (K915340) - FDA 510(k) Clearance

Class I Ophthalmic device.

K915340 · Mentor O & O, Inc. · Ophthalmic device
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Mar 1992
Decision
158d
Days
Class 1
Risk

K915340 is an FDA 510(k) clearance for the MENTOR HORIZON LOW VISION MAGNIFIER. Classified as System, Reading, Television, Closed-circuit (product code HJG), Class I - General Controls.

Submitted by Mentor O & O, Inc. (Norwell, US). The FDA issued a Cleared decision on March 30, 1992 after a review of 158 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5820 - 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 Mentor O & O, Inc. devices

Submission Details

510(k) Number K915340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1991
Decision Date March 30, 1992
Days to Decision 158 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
48d slower than avg
Panel avg: 110d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJG System, Reading, Television, Closed-circuit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5820
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.