510(k) K252633
K252633 is an FDA 510(k) premarket notification submitted by Cylite Pty. , Ltd. for the device "UNITY DX (UDX)". The FDA issued a decision of Substantially Equivalent on December 23, 2025. The device falls under product code OBO (Tomography, Optical Coherence), a Class II device regulated under 21 CFR 886.1570. Cylite Pty. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2025
- Date Received
- August 20, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tomography, Optical Coherence
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.