QQJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Applicator, Negative Pressure, External, Ocular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5000
- Medical specialty
- Ophthalmic
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FSYX Ocular Pressure Adjusting Pump (K252455) | Balance Ophthalmics, Inc. | 2026-04-30 |
| FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System (DEN230055) | Balance Ophthalmics, Inc. | 2024-06-27 |
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Every clearance here is in the API, with alerts when new ones post.