# K201724: Pentacam AXL Wave

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Optikgerate GmbH
- Decided: Oct 21, 2020 after 120 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K955442 (1996). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152311: Pentacam AXL, Oculus Optikgerate GmbH (2016) Summary page 4.
- K143086: VX120 Ophthalmic Diagnostic Device, Luneau Sas (2015) Summary page 4.

## Recalls of this device
- Aug 8, 2023 · Class II · Z-2482-2023: 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: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

## Indications for use
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.

Source page: https://510kreport.com/device/K201724
Methodology: https://510kreport.com/methodology