FSYX Ocular Pressure Adjusting Pump

Primary DI: 00860012858408
Brand: FSYX Ocular Pressure Adjusting Pump
Company: Balance Ophthalmics Inc.
Model: 400-6008-00
Device description: The FSYX OPAP connects to the OPAP Goggles through tubing to create the vacuum inside the Goggles.
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
Code	Name
QQJ	Applicator, Negative Pressure, External, Ocular

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
QQJ	Applicator, Negative Pressure, External, Ocular	Ophthalmic	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
DEN230055	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
DEN230055	000	FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System	Balance Ophthalmics, Inc.	2024-06-27	QQJ

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00860012858408	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00860012858408	00860012858408	860012858408	0860012858408

GMDN Terms#

Term, Definition table
Term	Definition
Intraocular pressure-reducing vacuum system pump	An electrically-powered, portable component of an intraocular pressure-reducing vacuum system designed for use by a healthcare professional to create and control negative pressure around the eye for the noninvasive, bilateral reduction of intraocular pressure (IOP) for the treatment of open-angle glaucoma. It is in the form of a small unit with connection points for suction and sensing tubing which are attached to the lenses of intraocular pressure-reducing vacuum system goggles (not included). 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 DI	Brand	Model	Catalog	Published
00860012858439	FSYX Goggles - Large	400-6009-003		2025-03-20
00860012858415	FSYX Goggles - Small	400-6009-001		2025-03-18
00860012858422	FSYX Goggles - Medium	400-6009-002		2025-03-18

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00860012858439	FSYX Goggles - Large	Balance Ophthalmics Inc.	QQJ	2025-03-20
00860012858415	FSYX Goggles - Small	Balance Ophthalmics Inc.	QQJ	2025-03-18
00860012858422	FSYX Goggles - Medium	Balance Ophthalmics Inc.	QQJ	2025-03-18