TSK OptiXion— 510(k) K262516
Substantially EquivalentTsk Laboratory, Japan
FDA 510(k) clearance K262516 for TSK OptiXion, Substantially Equivalent on 2026-10-06. Applicant: Tsk Laboratory, Japan. Device class: 2.
Summary
TSK OptiXion from Tsk Laboratory is filed under QYM, ophthalmic needles. The record doesn't give gauge, length, or intended procedures.
Class II, 21 CFR 880.5570. The General Hospital panel reviewed it as a Traditional 510(k).
Tsk Laboratory filed from Tochigi-ken, Japan. Review took 77 days (July 21 to October 6, 2026).
Clearance details
- Applicant
- Tsk Laboratory, Japan
- Product code
- Product code QYM
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tochigi-Ken, JP
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