# K122848: Lenstec LC Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Lenstec, Inc.
- Decided: Oct 18, 2013 after 395 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: 6 generations back to K930320 (1994). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063802: Lenstec LC Injection System, Lenstec, Inc. (2007) Summary page 1.

## Most influential descendants
- K161776: Lenstec LC Injection system (2016), 0 descendants of its own

## Indications for use
The Lenstec LC Injection System is intended for use in the implantation of the Softec HD, Softec I and Softec HD PS model Lenstec IOLs, as well as any IOL which has indicated for its use in its approved labeling, into the capsular bag following extracapsular extraction

Source page: https://510kreport.com/device/K122848
Methodology: https://510kreport.com/methodology