K-number	DEN230055
Device name	FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System
Applicant	Balance Ophthalmics, Inc.
Product code	QQJ
Device class	Class II
Decision date	Jun 27, 2024
Decision	Not Substantially Equivalent
Regulation	886.5000

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View the full FDA submission: accessdata.fda.gov

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FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System

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FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System