| Primary Device ID | 00860012858439 |
| NIH Device Record Key | eaed4672-dc7a-4c4c-a005-0504d4b1d364 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FSYX Goggles - Large |
| Version Model Number | 400-6009-003 |
| Company DUNS | 119381400 |
| Company Name | Balance Ophthalmics Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860012858439 [Primary] |
| QQJ | Applicator, Negative Pressure, External, Ocular |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-28 |
| Device Publish Date | 2025-03-20 |
| 00860012858439 - FSYX Goggles - Large | 2025-03-28The FSYX OPAP Goggles fit around the eyes to create a seal |
| 00860012858439 - FSYX Goggles - Large | 2025-03-28 The FSYX OPAP Goggles fit around the eyes to create a seal |
| 00860012858408 - FSYX Ocular Pressure Adjusting Pump | 2025-03-26 The FSYX OPAP connects to the OPAP Goggles through tubing to create the vacuum inside the Goggles. |
| 00860012858415 - FSYX Goggles - Small | 2025-03-26 The FSYX OPAP Goggles fit around the eyes to create a seal |
| 00860012858422 - FSYX Goggles - Medium | 2025-03-26 The FSYX OPAP Goggles fit around the eyes to create a seal |