# K073023: Sterils Single-Use I/a Handpieces

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb, Inc.
- Decided: Mar 12, 2008 after 138 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 K912739 (1991). 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)
- K951463: Storz I/a Handpieces, Storz Instrument Co. (1995) Summary page 2.
- K912739: Site 90 Tip, I/a Handpiece .3MM Side Open/Opth Use, Site Microsurgical Systems, Inc. (1991) Summary page 2.

## Indications for use
The Bausch & LombTM Sterile Single-Use I/A Handpieces are used following phacoemulsification, an anterior surgical procedure to fragment and remove a cataractous lens. The eye is infused with Balanced Salt Solution (BSS) via the irrigation function, while the cortical material, viscoelastic, and excess BSS is removed via the aspiration function. I/A handpieces are also used for polishing the capsular bag to remove residual lens epithelial cells from the capsular membrane following extraction of the lens material.

Source page: https://510kreport.com/device/K073023
Methodology: https://510kreport.com/methodology