Clearance Summary
Tixel i (TXLI0001) received FDA 510(k) clearance under submission number K240512, sponsored by Novoxel , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2024-11-04.
- Submission: K240512
- Applicant / Sponsor: Novoxel , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5200
- Decision date: 2024-11-04
Classification & Regulation
This clearance is catalogued under FDA product code ORZ and 21 CFR 886.5200, within the Ophthalmic review panel as a Class II device.