Cleared Traditional

SYSTEMS OF SIGHT LOW VISION EYEWARE (K854854) - FDA 510(k) Clearance

Class I Ophthalmic device.

K854854 · Int'L Eye Care, Inc. · Ophthalmic device
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Feb 1986
Decision
61d
Days
Class 1
Risk

K854854 is an FDA 510(k) clearance for the SYSTEMS OF SIGHT LOW VISION EYEWARE. Classified as Spectacle, Magnifying (product code HOI), Class I - General Controls.

Submitted by Int'L Eye Care, Inc. (Rochester, US). The FDA issued a Cleared decision on February 4, 1986 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5840 - 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 Int'L Eye Care, Inc. devices

Submission Details

510(k) Number K854854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1985
Decision Date February 04, 1986
Days to Decision 61 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 110d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOI Spectacle, Magnifying
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5840
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.