Cleared Traditional

K262516 - TSK OptiXion

K262516 is an FDA 510(k) clearance for TSK OptiXion, manufactured by Tsk Laboratory, Japan. The device is a Class 2 General Hospital device with product code QYM cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K262516 · Tsk Laboratory, Japan · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
77d
Days
Class 2
Risk

K262516 is an FDA 510(k) clearance for the TSK OptiXion. Classified as Ophthalmic Needle (product code QYM), Class II - Special Controls.

Submitted by Tsk Laboratory, Japan (Tochigi-Ken, JP). The FDA issued a Cleared decision on October 6, 2026 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262516

510(k) Number K262516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2026
Decision Date October 06, 2026
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QYM Device Classification - Class 2, Special Controls

Product Code QYM Ophthalmic Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
Definition An Ophthalmic Needle Is A Needle Intended For Intraocular Injections. The Device Should Be Used By Health Care Professionals To Perform Injections Into The Eye.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

NAMSA
Anna Galea

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

K262516 · TSK OptiXion
Download PDF FDA Summary Tsk Laboratory, Japan