510(k) · Cleared

Cleared

Ladarwave Customcornea Wavefront System

K062930510(k) AbbreviatedCleared Nov 8, 200641-day reviewClass I21 CFR 886.1760

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alcon Research, Ltd. · NCF Aberrometer, Ophthalmic

Cleared on Nov 8, 2006 as substantially equivalent to K023249 (Alcon Laboratories, Inc., 2002) after a 41-day review. Its family tree reaches back 2 generations to 2000.

Decided: Nov 8, 2006
Review: 41 days
Class: Class I
Product code: NCF
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K000637 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK000637 Customcornea Measurement Device (CCMD)Alcon Laboratories, Inc. · 2000
1 generation backK023249 Alcon Ladarwave Customcornea Wavefront SystemAlcon Laboratories, Inc. · 2002 · Recalled
This deviceK062930 Ladarwave Customcornea Wavefront SystemAlcon Research, Ltd. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000637	Customcornea Measurement Device (CCMD)	Alcon Laboratories, Inc.	2000	—
−1	K023249	Alcon Ladarwave Customcornea Wavefront System	Alcon Laboratories, Inc.	2002	1
0 (this device)	K062930	Ladarwave Customcornea Wavefront System	Alcon Research, Ltd.	2006	—

FIG. 1 — Lineage of K062930, 2000–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NCF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K023249	Alcon Ladarwave Customcornea Wavefront System Summary page 1 …ass: 21 CFR 886.7160 Class I Product Code: NCF C. Substantial Equivalence Device (Predicate): LADARWave® CustomCornea®o Wavefront System (K023249) 0. Indications for Use: The LADARWave® CustomiCornea® Wavefiront System is used for measuring, recording, and an…	Alcon Laboratories, Inc.	2002	1

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All NCF devices

NCF Aberrometer, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NCF

FDA has decided no NCF device since 2007.

Median 510(k) review, days · NCF

Too few NCF 510(k)s in any year since 2007 to give a median.

Recalls per year · NCF

No recall names NCF since 2007.

Adverse event reports per year · NCF

39in 2025

2007high 148 (2018) · low 0 (2007)2025

MAUDE reports naming product code NCF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	22
2017	—	125
2018	—	148
2019	—	71
2020	—	53
2021	—	46
2022	—	38
2023	—	36
2024	—	34
2025	—	39
2026	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062930 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062930: Ladarwave Customcornea Wavefront System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062930

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026