Cleared Traditional

K944022 - LENSCHEK

K944022 is an FDA 510(k) clearance for LENSCHEK, manufactured by Leica, Inc.. The device is a Class 1 Ophthalmic device with product code HLM cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K944022 · Leica, Inc. · Ophthalmic device
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Nov 1994
Decision
92d
Days
Class 1
Risk

K944022 is an FDA 510(k) clearance for the LENSCHEK. Classified as Instrument, Measuring, Lens, Ac-powered (product code HLM), Class I - General Controls.

Submitted by Leica, Inc. (Buffalo, US). The FDA issued a Cleared decision on November 17, 1994 after a review of 92 days - within the typical 510(k) review window.

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 Leica, Inc. devices

FDA 510(k) Submission Details - K944022

510(k) Number K944022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1994
Decision Date November 17, 1994
Days to Decision 92 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
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

HLM Device Classification - Class 1, General Controls

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.

Regulatory Peers - HLM Instrument, Measuring, Lens, Ac-powered

All 9
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