510(k) · Cleared
Recalled · Class II · 2023Pentacam AXL Wave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oculus Optikgerate GmbH · MXK Device, Analysis, Anterior Segment
Cleared on Oct 21, 2020 as substantially equivalent to K152311 (Oculus Optikgerate GmbH, 2016) and 1 other predicate after a 120-day review. Its family tree reaches back 8 generations to 1996. It has been recalled 2 times.
- Decided
- Oct 21, 2020
- Review
- 120 days
- Class
- Class II
- Product code
- MXK
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 8 generations to K955442 (1996). 26 ancestors in all, the oldest K781994 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 7 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 6 generations backK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- 5 generations backK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- 4 generations backK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- 3 generations backK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
- 2 generations backK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
- 1 generation backK152311 Pentacam AXLOculus Optikgerate GmbH · 2016 · Recalled
- This deviceK201724 Pentacam AXL WaveOculus Optikgerate GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −7 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −6 | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| −5 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| −4 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| −3 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
| −2 | K122418 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2013 | 4 |
| −1 | K152311 | Pentacam AXL | Oculus Optikgerate GmbH | 2016 | 3 |
| 0 (this device) | K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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 MXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MXK device
- #1 K251848 Pentacam® Cornea OCTscore 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K152311 | Pentacam AXLSummary page 4….F.R. § 886.1850 Device class: II Product Code: MXK, HJO Predicate Devices Primary Predicate: OCULUS Optikgeräte GmbH, Pentacam AXL (K152311) Secondary Predicate: LUNEAU SAS, VX120 (K143086) Page 1 of 10… | 2016 |
| * | K143086 | VX120 Ophthalmic Diagnostic DeviceSummary page 4…Product Code: MXK, HJO Predicate Devices Primary Predicate: OCULUS Optikgeräte GmbH, Pentacam AXL (K152311) Secondary Predicate: LUNEAU SAS, VX120 (K143086) Page 1 of 10… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2023 | Class II | Z-2482-2023 | Process control | Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements. |
| Jul 8, 2022 | Class II | Z-1672-2022 | Software design | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 26 ancestors have a recall of any class.
- 2 other devices also cite its predicate K152311.
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MXK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXK
Too few MXK 510(k)s in any year since 2007 to give a median.
Recalls per year · MXK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXK
1in 2025
MAUDE reports naming product code MXK, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Pentacam AXL Wave is intended to image the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens. It is indicated for the evaluation of - corneal shape, - condition of the lens (opaque crystalline lens), - the anterior chamber angle, - anterior chamber depth, - the volume of the anterior chamber, - anterior or posterior cortical opacity, - the location of cataracts using cross slit imaging with densitometry, -…
Read the full statement (113 words)
The Pentacam AXL Wave is intended to image the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens. It is indicated for the evaluation of
- corneal shape,
- condition of the lens (opaque crystalline lens),
- the anterior chamber angle,
- anterior chamber depth,
- the volume of the anterior chamber,
- anterior or posterior cortical opacity,
- the location of cataracts using cross slit imaging with densitometry,
- corneal thickness,
- axial length,
- white-to-white distance,
- optical aberrations of the eye,
- and retroillumination imaging.
The Pentacam AXL Wave also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201724 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201724: Pentacam AXL Wave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201724
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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