# K062930: Ladarwave Customcornea Wavefront System

- Pathway: 510(k) (Abbreviated)
- Applicant: Alcon Research, Ltd.
- Decided: Nov 8, 2006 after 41 days
- Product code: NCF (Aberrometer, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 886.1760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000637 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023249: Alcon Ladarwave Customcornea Wavefront System, Alcon Laboratories, Inc. (2002) Summary page 1.

## 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 where a wavefront-guided treatment is indicated. This device can also export centration data and associated registration information for conventional phoropter-based refractive surgery with the LADAR6000T h System.

Source page: https://510kreport.com/device/K062930
Methodology: https://510kreport.com/methodology