# K200057: bioli lOL Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Ast Products, Inc.
- Decided: Jun 4, 2020 after 143 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- 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
Longest line of descent: 3 generations back to K001157 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182965: BL-Cart IOL Delivery Cartridge, Ast Products, Inc. (2019) Summary page 4.

## Indications for use
The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is for implantation of qualified Lenstec Softec 1 IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.

Source page: https://510kreport.com/device/K200057
Methodology: https://510kreport.com/methodology