Cleared Traditional

CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)

K000637 · Alcon Laboratories, Inc. · Ophthalmic
May 2000
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K000637 is an FDA 510(k) clearance for the CUSTOMCORNEA MEASUREMENT DEVICE (CCMD), a Aberrometer, Ophthalmic (Class I — General Controls, product code NCF), submitted by Alcon Laboratories, Inc. (Orlando, US). The FDA issued a Cleared decision on May 19, 2000, 84 days after receiving the submission on February 25, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1760.

Submission Details

510(k) Number K000637 FDA.gov
FDA Decision Cleared SESU
Date Received February 25, 2000
Decision Date May 19, 2000
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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

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