510(k) Report

510(k) · Decided

Decided

Customcornea Measurement Device (CCMD)

K000637510(k) TraditionalDecided May 19, 200084-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 Laboratories, Inc. · NCF Aberrometer, Ophthalmic

Cleared on May 19, 2000 after an 84-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
May 19, 2000
Review
84 days
Class
Class I
Product code
NCF
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2006: 1 descendant cleared200020052010201520202025
  1. This deviceK000637 Customcornea Measurement Device (CCMD)Alcon Laboratories, Inc. · 2000
  2. Descendant · cites it directly · 1 of its ownK023249 Alcon Ladarwave Customcornea Wavefront SystemAlcon Laboratories, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK062930 Ladarwave Customcornea Wavefront SystemAlcon Research, Ltd. · 2006

Most influential descendants

Showing 2 of 2 · See all
  • K023249Alcon Ladarwave Customcornea Wavefront SystemAlcon Laboratories, Inc. · 2002 · cites it directly1descendant
  • K062930Ladarwave Customcornea Wavefront SystemAlcon Research, Ltd. · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000637Customcornea Measurement Device (CCMD)Alcon Laboratories, Inc.2000—
+1K023249Alcon Ladarwave Customcornea Wavefront SystemAlcon Laboratories, Inc.20021
+2K062930Ladarwave Customcornea Wavefront SystemAlcon Research, Ltd.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200610
FIG. 1 — Lineage of K000637, 2000–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023249Alcon Ladarwave Customcornea Wavefront SystemAlcon Laboratories, Inc.20021

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?

  • Of its descendants, K023249 (Alcon Laboratories, Inc., 2002) has gone furthest, with 1 descendant of its own.

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

2016: 222017: 1252018: 1482019: 712020: 532021: 462022: 382023: 362024: 342025: 39
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—022
20170—0125
20180—0148
20190—071
20200—053
20210—046
20220—038
20230—036
20240—034
20250—039
20260—0—

More from Alcon Laboratories, Inc.

489 FDA decisions under this applicant name. See the company

  • P930014/S164AcrySof® Posterior Chamber Intraocular Lens and Delivery SystemsAlcon Laboratories, Inc. · 2026
  • P930014/S163Acrosof Posterior Chamber Intraocular LensAlcon Laboratories, Inc. · 2026
  • P930014/S165AcrySof® Posterior Chamber Intraocular Lens and Delivery SystemsAlcon Laboratories, Inc. · 2026
  • P010019/S087Focus Night and Day (Lotrafilcon a) Soft Contact LensesAlcon Laboratories, Inc. · 2026
  • P930014/S161AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL…Alcon Laboratories, Inc. · 2026

Recent decisions in NCF

The NCF category page

  • K062930Ladarwave Customcornea Wavefront SystemAlcon Research, Ltd. · 2006
  • K050336Opd-Station SoftwareNidek, Inc. · 2005
  • K023249Alcon Ladarwave Customcornea Wavefront SystemAlcon Laboratories, Inc. · 20021 recall

https://510kreport.com/device/K000637 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000637: Customcornea Measurement Device (CCMD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000637

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026