FSYX Goggles - Small

Primary DI
00860012858415
Brand
FSYX Goggles - Small
Company
Balance Ophthalmics Inc.
Model
400-6009-001
Device description
The FSYX OPAP Goggles fit around the eyes to create a seal
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QQJApplicator, Negative Pressure, External, Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQJApplicator, Negative Pressure, External, OcularOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230055000FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) SystemBalance Ophthalmics, Inc.2024-06-27QQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012858415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012858415008600128584158600128584150860012858415

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular pressure-reducing vacuum system gogglesA non-powered, portable component of an intraocular pressure-reducing vacuum system designed for the noninvasive, bilateral reduction of intraocular pressure (IOP) by creating a reduced pressure environment around the eye for the treatment of open-angle glaucoma. It is in the form of a pair of goggles, worn by the patient during treatment sessions in a clinical setting, with tubing attached to the lenses intended to be connected to a pump (not included) to monitor pressure and regulate suction applied to the microenvironment in front of the eye. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119381400
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012858439FSYX Goggles - Large400-6009-0032025-03-20
00860012858408FSYX Ocular Pressure Adjusting Pump400-6008-002025-03-18
00860012858422FSYX Goggles - Medium400-6009-0022025-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012858439FSYX Goggles - LargeBalance Ophthalmics Inc.QQJ2025-03-20
00860012858408FSYX Ocular Pressure Adjusting PumpBalance Ophthalmics Inc.QQJ2025-03-18
00860012858422FSYX Goggles - MediumBalance Ophthalmics Inc.QQJ2025-03-18