# K955789: Alcon Series 20000 Legacy Mackool System

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: Mar 21, 1996 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 K831836 (1983). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926512: Storz Modified Phaco Needle with Insulation Sleeve, Storz (1993) Summary page 2.
- K831836: Epsilon Ultrasonic Tip, CooperVision, Inc. (1983) Summary page 2.
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 2.
- K861380: Series Ten Thousand Master, CooperVision, Inc. (1986) Summary page 2.

## Most influential descendants
- K060648: Reprocessed Phacoemulsification Tips (2007), 0 descendants of its own
- K031404: Dignity Ophthalmic Surgical System (2003), 0 descendants of its own

## Indications for use
The intended use of this device is the automated phacoemulsification of a cataractous natural crystalline lens.

Source page: https://510kreport.com/device/K955789
Methodology: https://510kreport.com/methodology