# K050638: Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Lenstec, Inc.
- Decided: May 31, 2005 after 81 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 K930320 (1994). 6 ancestors in all.
12 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)
- K040837: Multiject Injector and Microglide Cartridge, Medicel AG (2004) Summary page 2.
- K980696: Foam Tip Injector, Staar Surgical Co. (1998) Summary page 2.

## Most influential descendants
- K060533: Lenstec Intraocular Lens (Iol) Injection System (2006), 11 descendants of its own
- K063802: Lenstec LC Injection System (2007), 10 descendants of its own
- K103495: Asico Softip Injector System (2011), 7 descendants of its own
- K142056: Lioli Iol Delivery System (2015), 6 descendants of its own
- K172228: pioli IOL Delivery System (2017), 5 descendants of its own

## Indications for use
The Lenstec IOL Injection System if intended for use in implantation of the Lenstec TetraflexTM Accommodating Posterior Chamber Intraocular Lens into the capsular bag following extracapsular extraction.

Source page: https://510kreport.com/device/K050638
Methodology: https://510kreport.com/methodology