Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027866078

FEI Number

3027866078

Entity Name

Balance Ophthalmics, Inc.

City/State/Country

Sioux Falls, SD, US

Establishment Address

3101 W 57th Street, Sioux Falls, SD 57108, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Balance Ophthalmics, Inc. (Owner Number: 10088563)

Owner / Operator Contact Address

3101 W 57th Street, Sioux Falls, SD 57108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN230055

PMA Number

N/A

All Registered Proprietary Names

FSYX Ocular Pressure Adjusting Pump

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QQJ	Applicator, Negative Pressure, External, Ocular	Ophthalmic	Class 2	886.5000	2024-10-22

Official Correspondent

Gary Mocnik

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Balance Ophthalmics, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027866078. Last updated year: 2026. Please use registration number 3027866078 when referencing this establishment in official correspondence.