510(k) DEN230055
- Device
- FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System
- Applicant
- Balance Ophthalmics, Inc.
- 510(k) number
- DEN230055
- Product code
- QQJ
- Decision
- Unknown (DENG)
- Decision date
- 2024-06-27
- Date received
- 2023-08-25
- Regulation
- 886.5000
- Classification name
- Applicator, Negative Pressure, External, Ocular
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Gary Mocnik
- Address
- 3101 W 57th St. Sioux Falls SD US 51708 51708
FDA Registration Numbers#
- 3027866078
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QQJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252455 | FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. | 2026-04-30 |