FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System— 510(k) DEN230055

Name: FDA 510(k) clearance DEN230055
Creator: U.S. Food and Drug Administration
Published: 2024-06-27

Unknown

Balance Ophthalmics, Inc.

FDA 510(k) clearance DEN230055 for FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System, Unknown on 2024-06-27. Applicant: Balance Ophthalmics, Inc.. Device class: 2.

Clearance details

Applicant: Balance Ophthalmics, Inc.
Product code: Code QQJ
Device class: Class 2
Regulation: 21 CFR 886.5000
Advisory panel: Ophthalmic
Date received: 2023-08-25
Decision date: 2024-06-27
Decision: Unknown
Clearance type: Direct
Location: Sioux Falls, SD, US

View on FDA.gov ↗

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