QQJ
- Product code
- QQJ
- Device name
- Applicator, Negative Pressure, External, Ocular
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.5000
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252455 | 2026-04-30 | Balance Ophthalmics, Inc. | FSYX Ocular Pressure Adjusting Pump | |
| DEN230055 | 2024-06-27 | Balance Ophthalmics, Inc. | FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) Sy… | — |
Official FDA classification page: QQJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).