# K250501: System Sophi

- Pathway: 510(k) (Traditional)
- Applicant: This AG
- Decided: Nov 14, 2025 after 267 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: 10 generations back to K933880 (1994). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213467: EVA NEXUS Ophthalmic Surgical System, D.O.R.C. Dutch Ophthalmic Research Center (International) (2022) Summary page 5.

## Indications for use
The System Sophi is an integrated phacoemulsification lens removal device designed for use in intraocular ophthalmic surgery in the anterior chamber. System Sophi is intended for liquid irrigation and aspiration, lens fragmentation and ultrasonic phacoemulsification, anterior vitrectomy, and bipolar diathermy (high frequency surgical equipment).

Source page: https://510kreport.com/device/K250501
Methodology: https://510kreport.com/methodology