FDA Product Code
FDA Product Code QQJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.5000
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252455 | FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. | 2026-04-30 | Traditional | PDF ↗ |
| DEN230055 | FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System | Balance Ophthalmics, Inc. | 2024-06-27 | Direct | — |
Product code QQJ · Class II · Ophthalmic. Data: openFDA.