510(k) · Cleared
ClearedAllegro Oculyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wavelight AG · MXK Device, Analysis, Anterior Segment
Cleared on Jul 20, 2007 as substantially equivalent to K030719 (Oculus Optikgerate GmbH, 2003) after an 81-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jul 20, 2007
- Review
- 81 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955442 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 2 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 1 generation backK030719 Pentacam Scheimpflug CameraOculus Optikgerate GmbH · 2003 · Recalled
- This deviceK071183 Allegro OculyzerWavelight AG · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −2 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −1 | K030719 | Pentacam Scheimpflug Camera | Oculus Optikgerate GmbH | 2003 | 1 |
| 0 (this device) | K071183 | Allegro Oculyzer | Wavelight AG | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (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 |
|---|---|---|---|
| * | K030719 | Pentacam Scheimpflug CameraSummary page 1…Panel: Ophthalmology 3. Predicate Devices The ALLEGRO Oculyzer system is substantially equivalent to the Oculus Pentacam Scheimpfiug Camera system (K03071 9). 4. Device Description The ALLEGRO Oculyzer Scheimpflug Camera is based on the Scheimpflug principle for slit lamp photog… | 2003 |
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 11 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 4 other devices also cite its predicate K030719.
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 ALLEGRO OcUlyzer is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber and the lens of the eye.
To evaluate:
* Corneal shape
* Analyze condition of the lens (opaque crystalline lens)
* Analyze the anterior chamber angle
* Analyze the anterior chamber depth
* Analyze he volume of the anterior chamber
* Analyze the anterior and posterior cortical opacity
* Analyze the location of the cataracts (nuclear, subcapsular and or cortical), using cross-lit images with densitometry
* Corneal thickness
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071183 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071183: Allegro Oculyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071183
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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