Cleared Traditional

K782118 - FUL-VUE (FDA 510(k) Clearance)

Class I Ophthalmic device.

K782118 · American Optical Corp. · Ophthalmic device
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Jan 1979
Decision
30d
Days
Class 1
Risk

K782118 is an FDA 510(k) clearance for the FUL-VUE. Classified as Refractor, Manual, Non-powered, Including Phoropter (product code HKN), Class I - General Controls.

Submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1979 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1770 - 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 American Optical Corp. devices

Submission Details

510(k) Number K782118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date January 26, 1979
Days to Decision 30 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 110d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKN Refractor, Manual, Non-powered, Including Phoropter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1770
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.