3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)— 510(k) K231222

Substantially Equivalent

Topcon Corporation

FDA 510(k) clearance K231222 for 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2), Substantially Equivalent on 2023-10-30. Applicant: Topcon Corporation.

Clearance details

Applicant: Topcon Corporation
Product code: Code OBO
Advisory panel: Ophthalmic
Date received: 2023-04-28
Decision date: 2023-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Itabashi-Ku, JP

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