Clearance Summary
CureSight-CS100 received FDA 510(k) clearance under submission number K221375, sponsored by Novasight , 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 2022-09-29.
- Submission: K221375
- Applicant / Sponsor: Novasight , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5500
- Decision date: 2022-09-29
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.