# K200207: xPORT S Lens Fragmentation System

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec Cataract Technology, Inc.
- Decided: Oct 15, 2020 after 261 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use of the xPORT S Lens Fragmentation System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting

Source page: https://510kreport.com/device/K200207
Methodology: https://510kreport.com/methodology