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510(k) K253039

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA by Topcon Corporation — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2025
Date Received
September 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

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