# K042139: Visulas Yag Iii

- Pathway: 510(k) (Special)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Sep 9, 2004 after 31 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VISULAS YAG II Plus: named in the summary without a submission number

## Most influential descendants
- K140336: Optimus Fusion: SLT, Yag and Yag/SLT (2014), 3 descendants of its own
- K192045: Ophthalmic Yag Laser System YC-200 (2019), 1 descendant of its own
- K220430: Capsulo (2022), 0 descendants of its own
- K203130: Ophthalmic Yag Laser System YC-200 (2020), 0 descendants of its own

## Indications for use
This device will be used in ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.

Source page: https://510kreport.com/device/K042139
Methodology: https://510kreport.com/methodology