Clearance Summary
Systane iLux2 received FDA 510(k) clearance under submission number K200400, sponsored by Tear Film Innovations, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2020-05-21.
- Submission: K200400
- Applicant / Sponsor: Tear Film Innovations, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5200
- Decision date: 2020-05-21
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.