Clearance Summary
UNITY DX (UDX) received FDA 510(k) clearance under submission number K252633, sponsored by Cylite Pty. , 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 2025-12-23.
- Submission: K252633
- Applicant / Sponsor: Cylite Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2025-12-23
Classification & Regulation
This clearance is catalogued under FDA product code OBO and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.