Clearance Summary
Luminopia One received FDA 510(k) clearance under submission number DEN210005, sponsored by Luminopia, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2021-10-20.
- Submission: DEN210005
- Applicant / Sponsor: Luminopia, Inc.
- Clearance pathway: Direct
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5500
- Decision date: 2021-10-20
Classification & Regulation
This clearance is catalogued under FDA product code QQU and 21 CFR 886.5500, within the Ophthalmic review panel as a Class II device.