Tomey Cornea/Anterior Segment OCT (CASIA2)— 510(k) K250553

Substantially Equivalent

Tomey Corporation

FDA 510(k) clearance K250553 for Tomey Cornea/Anterior Segment OCT (CASIA2), Substantially Equivalent on 2025-07-18. Applicant: Tomey Corporation.

Clearance details

Applicant: Tomey Corporation
Product code: Code OBO
Advisory panel: Ophthalmic
Date received: 2025-02-25
Decision date: 2025-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nagoya, JP

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