# K974469: Mentor Phacoemulsification Sistem Remote Control

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Feb 24, 1998 after 90 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: 1 generation back to K925828 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952213: Alcon Series 20000 Legacy Phacoemulsifier, Alcon Laboratories (1995) Summary page 2.
- K925828: Modified Site TXR Systems, Site Microsurgical Systems, Inc. (1994) Summary page 2.

## Indications for use
The Mentor® Phacoemulsification SIStem Remote Control is intended to be used by operating room personnel to control the main functions of the Mentor Phacoemulsification SIStem from a distance.

Source page: https://510kreport.com/device/K974469
Methodology: https://510kreport.com/methodology