AccessGUDID - DEVICE: FSYX Goggles - Small (00860012858415)

GUDID

Device Identifier (DI) Information

Brand Name: FSYX Goggles - Small
Version or Model: 400-6009-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Balance Ophthalmics Inc.

Primary DI Number: 00860012858415
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119381400 *Terms of Use

Device Description: The FSYX OPAP Goggles fit around the eyes to create a seal

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
67473	Intraocular pressure-reducing vacuum system goggles	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QQJ	Applicator, Negative Pressure, External, Ocular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN230055	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2363b2dd-8131-4a54-9919-ae2dd8823d65
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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