510(k) clearance
TSK OptiXion
- 510(k) number
- K262516
- Applicant
- Tsk Laboratory, Japan
- Decision date
- Oct 6, 2026
- Date received
- Jul 21, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QYM
- Device type
- Ophthalmic Needle
- Device class
- Class II
- Regulation
- 21 CFR 880.5570
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Tochigi-Ken, JP