510(k) · Cleared
Recalled · 2003Alcon Ladarwave Customcornea Wavefront System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · NCF Aberrometer, Ophthalmic
Cleared on Oct 18, 2002 as substantially equivalent to K000637 (Alcon Laboratories, Inc., 2000) after an 18-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 18, 2002
- Review
- 18 days
- Class
- Class I
- Product code
- NCF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000637 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000637 Customcornea Measurement Device (CCMD)Alcon Laboratories, Inc. · 2000
- This deviceK023249 Alcon Ladarwave Customcornea Wavefront SystemAlcon Laboratories, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK062930 Ladarwave Customcornea Wavefront SystemAlcon Research, Ltd. · 2006
Most influential descendants
Showing 1 of 1 · See all- K062930Ladarwave Customcornea Wavefront SystemAlcon Research, Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000637 | Customcornea Measurement Device (CCMD) | Alcon Laboratories, Inc. | 2000 | — |
| 0 (this device) | K023249 | Alcon Ladarwave Customcornea Wavefront System | Alcon Laboratories, Inc. | 2002 | — |
| +1 | K062930 | Ladarwave Customcornea Wavefront System | Alcon Research, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K000637 | Customcornea Measurement Device (CCMD)Summary page 1…to the patient. The LADARWave"' CustoinCorneaK'Wavefront System is substantially equivalent to prior aberroineters and the predicate model approbed iinder K000637. Page 1 o f 2… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062930 | Ladarwave Customcornea Wavefront System | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2003 | Not classified | Z-1078-03 | Other | Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K062930 (Alcon Research, Ltd., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NCF devicesNCF 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
MAUDE reports naming product code NCF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 22 |
| 2017 | 0 | — | 0 | 125 |
| 2018 | 0 | — | 0 | 148 |
| 2019 | 0 | — | 0 | 71 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 46 |
| 2022 | 0 | — | 0 | 38 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 39 |
| 2026 | 0 | — | 0 | — |
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 with an indication for wavefront-guided refractive surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023249: Alcon Ladarwave Customcornea Wavefront System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023249
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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