# K031404: Dignity Ophthalmic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Phacor Inc., A Santen Company
- Decided: May 22, 2003 after 17 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: 3 generations back to K953575 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981116: Sovereign Cataract Extraction System, Allergan, Inc. (1998) Summary page 1.
- K955789: Alcon Series 20000 Legacy Mackool System, Alcon Laboratories (1996) Summary page 1.
- K980488: Storz Millennium Microsurgicl System High Speed Vitrectomy System, Storz Instrument Co. (1998) Summary page 1.

## Indications for use
The Dignity™ Ophthalmic Surgical System is a Phacofragmentation device intended for use in cataract surgery to emulsify, and extract the cataract.

Source page: https://510kreport.com/device/K031404
Methodology: https://510kreport.com/methodology