# K023249: Alcon Ladarwave Customcornea Wavefront System

- Pathway: 510(k) (Abbreviated)
- Applicant: Alcon Laboratories, Inc.
- Decided: Oct 18, 2002 after 18 days
- Product code: NCF (Aberrometer, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 886.1760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000637 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000637: Customcornea Measurement Device (CCMD), Alcon Laboratories, Inc. (2000) Summary page 1.

## Most influential descendants
- K062930: Ladarwave Customcornea Wavefront System (2006), 0 descendants of its own

## Recalls of this device
- Jul 21, 2003 · Not classified · Z-1078-03: Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly.

## Indications for use
The LADARWave CustomCornea Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, hyperopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections. This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser with an indication for wavefront-guided refractive surgery.

Source page: https://510kreport.com/device/K023249
Methodology: https://510kreport.com/methodology