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510(k) K252455

FSYX Ocular Pressure Adjusting Pump by Balance Ophthalmics, Inc. — Product Code QQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2026
Date Received
August 5, 2025
Clearance Type
Traditional
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.

Other clearances by Balance Ophthalmics, Inc.

  • DEN230055 — FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System (June 27, 2024)

Other clearances for product code QQJ

  • DEN230055 — FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System (June 27, 2024)