UNITY DX (UDX)— 510(k) K252633

Substantially Equivalent

Cylite Pty. , Ltd.

FDA 510(k) clearance K252633 for UNITY DX (UDX), Substantially Equivalent on 2025-12-23. Applicant: Cylite Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: Cylite Pty. , Ltd.
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2025-08-20
Decision date: 2025-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mulgrave, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.