# K152311: Pentacam AXL

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Optikgerate GmbH
- Decided: Jan 20, 2016 after 159 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K955442 (1996). 22 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122418: Iolmaster 500, Carl Zeiss Meditec, AG (2013) Summary page 4.
- K030719: Pentacam Scheimpflug Camera, Oculus Optikgerate GmbH (2003) Summary page 4.

## Most influential descendants
- K202989: Myopia Master (2021), 0 descendants of its own
- K201724: Pentacam AXL Wave (2020), 0 descendants of its own
- K182659: Galilei G6 Lens Professional (2019), 0 descendants of its own

## Recalls of this device
- Aug 8, 2023 · Class II · Z-2483-2023: 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-1673-2022: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
- Nov 21, 2017 · Class II · Z-0635-2018: The device software versions have an anomaly which may produce an erroneous marking for the quality specification value

## Indications for use
The Pentacam® is designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate: corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry, corneal thickness, axial length, white-to-white distance. The Pentacam® AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

Source page: https://510kreport.com/device/K152311
Methodology: https://510kreport.com/methodology