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FDA 510(k)

TSK OptiXion

K-Number: K262516 · 2026-10-06

ApplicantTsk Laboratory, Japan
Decision Date2026-10-06
Product CodeQYM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TSK OptiXion is the device name listed in this FDA 510(k) record. The listed applicant is Tsk Laboratory, Japan. It received FDA 510(k) clearance on 2026-10-06 under 510(k) number K262516. The device is classified under product code QYM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSK OptiXion?

TSK OptiXion is a medical device that received FDA 510(k) clearance on 2026-10-06. The listed applicant is Tsk Laboratory, Japan. The 510(k) number is K262516.

When did TSK OptiXion receive FDA 510(k) clearance?

TSK OptiXion received FDA 510(k) clearance on 2026-10-06, under 510(k) number K262516.

Who is the listed applicant for TSK OptiXion?

The FDA 510(k) record lists Tsk Laboratory, Japan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSK OptiXion?

The FDA product code for TSK OptiXion is QYM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Tsk Laboratory, Japan as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250127TSK SyringeK250284TSK SELECT™ NeedleK970370TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE

Related Devices (Code: QYM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KKK230951Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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