# K233398: Faros Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Oertli Instrumente AG
- Decided: Jun 27, 2024 after 268 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: 7 generations back to K844373 (1985). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133562: Catarhex 3, Oertli Instrumente AG (2014) Summary page 5.

## Indications for use
The Faros is a surgery system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation and aspiration, as well as ancillary functions such as vitreous cutting along with bipolar diathermy. Faros is used for these surgical interventions in the anterior eye segment: – Irrigation and aspiration (I/Afunction) – Ultrasound phaco (PHACO function) – Biopolar diathermy for hemostasis and coaptation of the conjunctiva (DIA function) – Bipolar diathermic capsulotomy (CAPS function) – Operation of a vitrectomy instrument (VIT function) The device may only be used with the instruments recommended and supplied by Oertli.

Source page: https://510kreport.com/device/K233398
Methodology: https://510kreport.com/methodology