Cleared Traditional

K925304 - AUTOREF LENSMETER RL-10 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K925304 · Canon USA, Inc. · Ophthalmic device
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Feb 1994
Decision
484d
Days
Class 1
Risk

K925304 is an FDA 510(k) clearance for the AUTOREF LENSMETER RL-10. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Canon USA, Inc. (Tokyo 146, JP). The FDA issued a Cleared decision on February 17, 1994 after a review of 484 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1760 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Canon USA, Inc. devices

Submission Details

510(k) Number K925304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1992
Decision Date February 17, 1994
Days to Decision 484 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
374d slower than avg
Panel avg: 110d · This submission: 484d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKO Refractometer, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1760
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.