DeviceClearance

ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM— 510(k) K023249

Substantially Equivalent

Alcon Laboratories, Inc.

FDA 510(k) clearance K023249 for ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM, Substantially Equivalent on 2002-10-18. Applicant: Alcon Laboratories, Inc.. Device class: 1.

Clearance details

Applicant
Alcon Laboratories, Inc.
Product code
Code NCF
Device class
Class 1
Regulation
21 CFR 886.1760
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Orlando, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NCF

product code NCF
Injury
129
Total
129

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.