# K220259: ALLY Adaptive Cataract Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Lensar, Inc.
- Decided: Jun 9, 2022 after 129 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: 16 generations back to K913697 (1991). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182795: LENSAR Laser System - fs 3D (LLS-fs 3D), Lensar, Inc. (2018) Summary page 4.

## Indications for use
The ALLY Adaptive Cataract Treatment System is an ophthalmic surgical laser indicated for use: • in the creation of an anterior capsulotomy. • in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens. • in the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea.

Source page: https://510kreport.com/device/K220259
Methodology: https://510kreport.com/methodology