HP-OCT (HP-OCT)— 510(k) K231760

Substantially Equivalent

Cylite Pty. , Ltd.

FDA 510(k) clearance K231760 for HP-OCT (HP-OCT), Substantially Equivalent on 2024-03-08. Applicant: Cylite Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: Cylite Pty. , Ltd.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2023-06-16
Decision date: 2024-03-08
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.