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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
510(k) Number K260108
Device Name L12 LED Light Source with AIM
Applicant
Stryker Endoscopy
5900 Optical Court
San Jose,  CA  95138
Applicant Contact Irina Glazkova
Correspondent
Stryker Endoscopy
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact Irina Glazkova
Regulation Number876.1500
Classification Product Code
OWN  
Subsequent Product Codes
FCS   FCW   GWG   NWB  
Date Received01/14/2026
Decision Date 02/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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