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510(k) K262516

Device
TSK OptiXion
Applicant
Tsk Laboratory, Japan
510(k) number
K262516
Product code
QYM
Decision
Substantially Equivalent (SESE)
Decision date
2026-10-06
Date received
2026-07-21
Regulation
880.5570
Classification name
Ophthalmic Needle
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Yumi Ueda
Address
1510-1, Soja-Machi, Tochigi-Shi Tochigi-Ken JP 328-0002 328-0002

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QYM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK2024-10-23
K230951Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V.2023-10-18