FDA.report

510(k) K260108

Device
L12 LED Light Source with AIM
Applicant
Stryker Endoscopy
510(k) number
K260108
Product code
OWN
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-12
Date received
2026-01-14
Regulation
876.1500
Classification name
Confocal Optical Imaging
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Irina Glazkova
Address
5900 Optical Ct. San Jose CA US 95138 95138

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker2023-09-20
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K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.2023-07-17
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