# K223838: Catalys™ Precision Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Amo Manufacturing USA, LLC
- Decided: Apr 12, 2023 after 111 days
- Product code: OOE (Ophthalmic Femtosecond Laser)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K913697 (1991). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200056: Catalys Precision Laser System, Amo Manufacturng USA, LLC (2020) Summary page 4.

## Indications for use
The CATALYS™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/ incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Source page: https://510kreport.com/device/K223838
Methodology: https://510kreport.com/methodology