# K111697: Amo Whitestar Signature Phacoemulsification System

- Pathway: 510(k) (Abbreviated)
- Applicant: Abbott Medical Optics, Inc.
- Decided: Sep 27, 2011 after 102 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: 2 generations back to K911808 (1991). 4 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K060366: The Amo Ophthalmic Surgical System, Advanced Medical Optics, Inc. (2006) Summary page 1.

## Most influential descendants
- K151636: AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control (2015), 1 descendant of its own
- K203060: VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (2021), 0 descendants of its own

## Indications for use
The AMO WHITESTAR Signature Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.

Source page: https://510kreport.com/device/K111697
Methodology: https://510kreport.com/methodology