Cleared Traditional

AL-3300 (K940997) - FDA 510(k) Clearance

Class I Ophthalmic device.

K940997 · Hoya Corp. USA · Ophthalmic device
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Sep 1994
Decision
209d
Days
Class 1
Risk

K940997 is an FDA 510(k) clearance for the AL-3300. Classified as Instrument, Measuring, Lens, Ac-powered (product code HLM), Class I - General Controls.

Submitted by Hoya Corp. USA (Lake Success, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 209 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1425 - 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 Hoya Corp. USA devices

Submission Details

510(k) Number K940997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1994
Decision Date September 29, 1994
Days to Decision 209 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 110d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLM Instrument, Measuring, Lens, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1425
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.