510(k) DEN230055

FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System by Balance Ophthalmics, Inc. — Product Code QQJ

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: June 27, 2024
Date Received: August 25, 2023
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Applicator, Negative Pressure, External, Ocular
Device Class: Class II
Regulation Number: 886.5000
Review Panel: OP
Submission Type

External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients.