# K191046: L10 LED Light Source with AIM, L11 LED Light Source with AIM

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: May 10, 2019 after 21 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K930667 (1994). 91 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173866: Stryker AIM Light Source and SafeLight cable, Stryker (2018) Summary page 4.
- K182160: 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM, Stryker (2018) Summary page 4.

## Most influential descendants
- K192292: L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable (2019), 1 descendant of its own
- K243591: OPTOVISION Endoscopic Light Source Unit (2025), 0 descendants of its own

## Indications for use
Upon intravenous administration of SPY AGENY'M GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight Cable are indicated for use with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K191046
Methodology: https://510kreport.com/methodology