L12
The L12 LED Light Source with AIM is part of the Advanced Imaging Modality system. Its filing describes visible white-light and near-infrared illumination and transillumination for…
The L12 LED Light Source with AIM is part of the Advanced Imaging Modality system. Its filing describes visible white-light and near-infrared illumination and transillumination for endoscopic imaging, including fluorescence imaging using indocyanine green or pafolacianine.
The light source also supports near-infrared transillumination of the ureters using the IRIS Ureteral Kit. The FDA text distinguishes the L12 illumination role from the wider endoscopic imaging system and identifies the modes it supports.
Listed Item
L12 LED Light Source With AIM
Illumination Modes
The L12 supports visible light, near-infrared fluorescence and near-infrared transillumination. With the specified kit, the indication includes visual assessment of vessels, blood flow and related tissue perfusion.
Who Else Makes It
Concentrated in Guangdong (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Wuxi Hisky Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | OWN |
| Device type | Confocal Optical Imaging |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K230754 |
| Record published | 2023-04-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0220240300 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VS3-IR | Visionsense, Ltd. | 22 |
| Confocal Microprobe Imaging System | Wuxi Hisky Medical Technologies Co., Ltd. | 16 |
| Confocal Optical Imaging | Karl Storz GmbH & Co. KG | 13 |
| Hopkins | Karl Storz GmbH & Co. KG | 4 |
| AIM (Advanced Imaging Modality) | Stryker GmbH | 4 |
| VS3-NE | Visionsense, Ltd. | 3 |
| Open Field Fluorescence Imaging Head | Guangdong Optomedic Technologies, Inc. | 3 |
| Cellvizio® 100 series (488nm) | Mauna KEA Technologies | 3 |
| Photonvue | Fluoptics SAS | 2 |
| VS3 Iridium | Visionsense, Ltd. | 2 |
| SafeLight | Stryker GmbH | 2 |
| 1588 AIM | Stryker GmbH | 2 |
Showing 12 of 74. All products under Confocal Optical Imaging
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231854 | 2023-09-20 |
| K230754 | 2023-04-11 |
| K221611 | 2022-06-29 |
| K192292 | 2019-11-19 |
| K191046 | 2019-05-10 |
| K173866 | 2018-01-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.