# K172228: pioli IOL Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Ast Products, Inc.
- Decided: Dec 15, 2017 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: 8 generations back to K930320 (1994). 13 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142056: Lioli Iol Delivery System, Ast Products, Inc. (2015) Summary page 4.

## Most influential descendants
- K181401: RxSight Insertion Device (2018), 4 descendants of its own
- K192926: RxSight Insertion Device (2020), 3 descendants of its own
- K231466: RxSight Insertion Device (2023), 2 descendants of its own
- K231838: RxSight® Insertion Device (63002) (2023), 1 descendant of its own
- K261174: RxSight® Insertion Device (2026), 0 descendants of its own

## Indications for use
The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.

Source page: https://510kreport.com/device/K172228
Methodology: https://510kreport.com/methodology