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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmic Needle
510(k) Number K262516
Device Name TSK OptiXion
Applicant
Tsk Laboratory, Japan
1510-1, Soja-Machi, Tochigi-Shi
Tochigi-Ken,  JP 328-0002
Applicant Contact Yumi Ueda
Correspondent
NAMSA
400 Hwy. 169 S.
Suite 500
Minneapolis,  MN  55426
Correspondent Contact Anna Galea
Regulation Number880.5570
Classification Product Code
QYM  
Subsequent Product Codes
FMI   QNS  
Date Received07/21/2026
Decision Date 10/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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