# K233911: VISULAS combi

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Sep 6, 2024 after 269 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: 9 generations back to K894841 (1989). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232051: VISULAS green, Carl Zeiss Meditec (2023) Summary page 6.
- K230350: VISULAS yag, Carl Zeiss Meditec, Inc. (2023) Summary page 6.

## Indications for use
VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including: • Photocoagulation of the retina • Trabeculoplasty • Iridotomy • Posterior capsulotomy • Posterior membranectomy

Source page: https://510kreport.com/device/K233911
Methodology: https://510kreport.com/methodology