FSYX Ocular Pressure Adjusting Pump— 510(k) K252455

Name: FDA 510(k) clearance K252455
Creator: U.S. Food and Drug Administration
Published: 2026-04-30

Substantially Equivalent

Balance Ophthalmics, Inc.

FDA 510(k) clearance K252455 for FSYX Ocular Pressure Adjusting Pump, Substantially Equivalent on 2026-04-30. 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: 2025-08-05
Decision date: 2026-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sioux Falls, SD, US

Download summary PDF View on FDA.gov ↗

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