# K221601: MS-39

- Pathway: 510(k) (Traditional)
- Applicant: C.S.O. S.R.L.
- Decided: Sep 1, 2023 after 456 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- 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
The MS-39 is designed to capture scans of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate: - anterior and posterior corneal shape (elevation maps, curvature maps, power maps); - anterior chamber features (Anterior Chamber Depth - ACD, Aqueous Depth - AD); - corneal thickness (Central Corneal Thickness - CCT, corneal thickness map); - corneal epithelia map; - corneal stroma map; - lens thickness.

Source page: https://510kreport.com/device/K221601
Methodology: https://510kreport.com/methodology