# K971064: Bayers Bimanual I/a Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Visioncare Devices, Inc.
- Decided: Jun 9, 1997 after 77 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Anterior Phaco emulsification cortex clean up.

Source page: https://510kreport.com/device/K971064
Methodology: https://510kreport.com/methodology