Cleared Traditional

K760949 - CHARLES IRRIGATING FUNDUS CONTACT LENS (FDA 510(k) Clearance)

Class I Ophthalmic device.

K760949 · Richard'S Medical Equip., Inc. · Ophthalmic device
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Nov 1976
Decision
10d
Days
Class 1
Risk

K760949 is an FDA 510(k) clearance for the CHARLES IRRIGATING FUNDUS CONTACT LENS. Classified as Lens, Fundus, Hruby, Diagnostic (product code HJI), Class I - General Controls.

Submitted by Richard'S Medical Equip., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 11, 1976 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1395 - 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 Richard'S Medical Equip., Inc. devices

Submission Details

510(k) Number K760949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1976
Decision Date November 11, 1976
Days to Decision 10 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 110d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJI Lens, Fundus, Hruby, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1395
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.