FDA 510(k) Application Details - DEN230055

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230055
Device Name	FSYXÖ Ocular Pressure Adjusting Pump (FSYXÖ OPAP) System
Applicant	Balance Ophthalmics, Inc. 3101 W 57th Street Sioux Falls, SD 51708 US Other 510(k) Applications for this Company
Contact	Gary Mocnik Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2023
Decision Date	06/27/2024
Decision	DENG -
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review