# K063694: Akreos Single Use Insertion Device, Model AI-28

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb, Inc.
- Decided: Mar 7, 2007 after 84 days
- Product code: KYB (Lens, Guide, Intraocular)
- Device class: 1
- Regulation: 21 CFR 886.4300
- 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) Passport foldable lens placement system: named in the summary without a submission number

## Indications for use
The Akreos Single Use Insertion Device should only be used to fold and deliver those IOL models that allow use of this injector in their approved labeling.

Source page: https://510kreport.com/device/K063694
Methodology: https://510kreport.com/methodology