# K082132: Bausch & Lomb D4600A Air Exchange Line Pack

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb, Inc.
- Decided: Aug 28, 2008 after 30 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 K832761 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962131: Storz D4600 Air Exchange Line Pack, Storz Instrument Co. (1996) Summary page 1.

## Indications for use
The Bausch & LombrM D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb STELLARIS® and Bausch & Lomb MILLENNIUM®, Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic procedures.

Source page: https://510kreport.com/device/K082132
Methodology: https://510kreport.com/methodology