FDA UDI
In Commercial Distribution
🇺🇸 United States
FSYX Ocular Pressure Adjusting Pump
DI: 00860012858408
·
Model: 400-6008-00
·
Balance Ophthalmics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FSYX Ocular Pressure Adjusting Pump
- Primary DI
- 00860012858408
- Version / Model
- 400-6008-00
- Company Name
- Balance Ophthalmics Inc.
- Labeler DUNS
- 119381400
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-18
- Public Version
- 1
- Public Version Date
- 2025-03-26
- Public Version Status
- New
- Public Device Record Key
- 03180a42-9362-45b0-ad34-7d8817389440
Device Description
The FSYX OPAP connects to the OPAP Goggles through tubing to create the vacuum inside the Goggles.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QQJ | Applicator, Negative Pressure, External, Ocular | Ophthalmic | 886.5000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67474 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012858408 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN230055 | 000 |