# K133562: Catarhex 3

- Pathway: 510(k) (Traditional)
- Applicant: Oertli Instrumente AG
- Decided: Aug 12, 2014 after 265 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
Longest line of descent: 6 generations back to K844373 (1985). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081877: Associate 2500 Dual and Compact Systems, Dutch Ophthalmic Research Center International BV (2009) Summary page 5.
- K101325: Stellaris PC Vision Enhancement System, Bausch & Lomb, Inc. (2010) Summary page 5.
- K001498: The Fugo Blade, Medisurg, Ltd. (2000) Summary page 5.

## Most influential descendants
- K233398: Faros Surgical System (2024), 0 descendants of its own

## Indications for use
The CataRhex 3 is used for surgical interventions in the anterior eye segment. Irrigation and aspiration (I/A function) Ultrasound phaco (PHACO function) Bipolar diathermy for hemostasis and welding of the conjunctiva (DIA function) Diathermic capsulotomy (CAPS function) Operation of a vitrectomy instrument (VIT function) The device may only be used with instruments recommended and supplied by Oertli Instrumente AG.

Source page: https://510kreport.com/device/K133562
Methodology: https://510kreport.com/methodology