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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Negative Pressure, External, Ocular
510(k) Number K252455
Device Name FSYX Ocular Pressure Adjusting Pump
Applicant
Balance Ophthalmics, Inc.
3101 W 57th St.
Sioux Falls,  SD  51708
Applicant Contact Gary Mocnik
Correspondent
Balance Ophthalmics, Inc.
3101 W 57th St.
Sioux Falls,  SD  51708
Correspondent Contact Gary Mocnik
Classification Product Code
QQJ  
Date Received08/05/2025
Decision Date 04/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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