Home / 510(k) Clearances / K232555

510(k) K232555

Harmony by Topcon Healthcare Solutions — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2023
Date Received
August 23, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Management, Ophthalmic
Device Class
Class II
Regulation Number
892.2050
Review Panel
OP
Submission Type

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