Cleared Traditional

ALES (K823385) - FDA 510(k) Clearance

Class I Ophthalmic device.

K823385 · Oms · Ophthalmic device
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Mar 1983
Decision
114d
Days
Class 1
Risk

K823385 is an FDA 510(k) clearance for the ALES. Classified as Aid, Vision, Electronic, Battery-powered (product code HPG), Class I - General Controls.

Submitted by Oms (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5900 - 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 Oms devices

Submission Details

510(k) Number K823385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1982
Decision Date March 09, 1983
Days to Decision 114 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 110d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPG Aid, Vision, Electronic, Battery-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5900
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.