# K071183: Allegro Oculyzer

- Pathway: 510(k) (Traditional)
- Applicant: Wavelight AG
- Decided: Jul 20, 2007 after 81 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955442 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030719: Pentacam Scheimpflug Camera, Oculus Optikgerate GmbH (2003) Summary page 1.

## Indications for use
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

Source page: https://510kreport.com/device/K071183
Methodology: https://510kreport.com/methodology