AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA— 510(k) K253039

Substantially Equivalent

Topcon Corporation

FDA 510(k) clearance K253039 for AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA, Substantially Equivalent on 2025-11-07. Applicant: Topcon Corporation.

Clearance details

Applicant: Topcon Corporation
Product code: Code HKX
Advisory panel: Ophthalmic
Date received: 2025-09-22
Decision date: 2025-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

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