Cylite Pty. , Ltd. is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Cylite Pty. , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: UNITY DX (UDX), HP-OCT (HP-OCT)
2
Total
2
Cleared
0
Denied
Cylite Pty. , Ltd. has 2 FDA 510(k) cleared medical devices. Based in Mulgrave, AU.
Latest FDA clearance: Dec 2025. Active since 2024. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Cylite Pty. , Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Orasi Consulting and Alcon Research, LLC. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Cylite Pty. , Ltd.
2 devices