# K230350: VISULAS yag

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Sep 22, 2023 after 225 days
- Product code: HQF (Laser, Ophthalmic)
- 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: 2 generations back to K021550 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212630: Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo, Ellex Medical Pty, Ltd. (2021) Summary page 5.

## Most influential descendants
- K233911: VISULAS combi (2024), 0 descendants of its own

## Indications for use
VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.

Source page: https://510kreport.com/device/K230350
Methodology: https://510kreport.com/methodology