# K962402: Amo Prestige Day Pack (Allergan, Inc.)

- Pathway: 510(k) (Traditional)
- Applicant: Allergan, Inc.
- Decided: Sep 19, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AMO® Prestige® Pack (Disposable, Sterile), OPO-40: named in the summary without a submission number
- (no number) AMO® One Bottle Reusable Tubing (Sterile): named in the summary without a submission number
- (no number) AMO® One Bottle Disposable Tubing (Sterile): named in the summary without a submission number
- (no number) AMO® Irrigation Administration Set (Sterile): named in the summary without a submission number
- (no number) AMO® T-Fitting (Non-Sterile): named in the summary without a submission number

## Indications for use
The AMO® Prestige® Day Pack supports the irrigation fluid path for replenishing intraocular fluid removed during cataract extraction. The tubing pack also supports the aspiration fluid path for removing fluid and nuclear fragments during cataract surgery.

Source page: https://510kreport.com/device/K962402
Methodology: https://510kreport.com/methodology