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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name applicator, negative pressure, external, ocular
De Novo Number DEN230055
Device Name FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System
Requester
balance ophthalmics, inc.
3101 w 57th st.
sioux falls,  SD  51708
Contact gary mocnik
Regulation Number886.5000
Classification Product Code
QQJ  
Date Received08/25/2023
Decision Date 06/27/2024
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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