Cleared Abbreviated

ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM

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

About This 510(k) Submission

K023249 is an FDA 510(k) clearance for the ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM, a Aberrometer, Ophthalmic (Class I — General Controls, product code NCF), submitted by Alcon Laboratories, Inc. (Orlando, US). The FDA issued a Cleared decision on October 18, 2002, 18 days after receiving the submission on September 30, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1760.

Submission Details

510(k) Number K023249 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NCF — Aberrometer, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1760

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