Cleared Abbreviated

K023249 - ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT ...

K023249 is the FDA 510(k) clearance for ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT ... by Alcon Laboratories, Inc.. It is a Class 1 Ophthalmic device (product code NCF) cleared through the Abbreviated 510(k) pathway after a 18-day FDA review.

K023249 · Alcon Laboratories, Inc. · Ophthalmic device
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Oct 2002
Decision
18d
Days
Class 1
Risk

K023249 is an FDA 510(k) clearance for the ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM. Classified as Aberrometer, Ophthalmic (product code NCF), Class I - General Controls.

Submitted by Alcon Laboratories, Inc. (Orlando, US). The FDA issued a Cleared decision on October 18, 2002 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1760 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Alcon Laboratories, Inc. devices

Submission Details

510(k) Number K023249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date October 18, 2002
Days to Decision 18 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 110d · This submission: 18d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NCF Aberrometer, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1760
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.