# K222933: MYAH

- Pathway: 510(k) (Traditional)
- Applicant: Visia Imaging S.R.L.
- Decided: Jun 29, 2023 after 276 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
MYAH is intended to be used by an eye care professional: • to measure the axial length of the eye in a population age 5 and above • to capture and store digital images of the meibomian glands under near-infrared illumination in adult population. MYAH is not intended to be used in patients with cataracts.

Source page: https://510kreport.com/device/K222933
Methodology: https://510kreport.com/methodology