# K202989: Myopia Master

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Optikgeräte GmbH
- Decided: Jul 14, 2021 after 287 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: 1 (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). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 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.
- K073508: Parkone, Oculus Optikgerate GmbH (2008) Summary page 4.

## Recalls of this device
- Aug 8, 2023 · Class II · Z-2484-2023: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

## Indications for use
The Myopia Master is an interferometer indicated for measuring the axial length of the eye and is intended as an aid to eye care providers.

Source page: https://510kreport.com/device/K202989
Methodology: https://510kreport.com/methodology