510(k) K252455
- Device
- FSYX Ocular Pressure Adjusting Pump
- Applicant
- Balance Ophthalmics, Inc.
- 510(k) number
- K252455
- Product code
- QQJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-30
- Date received
- 2025-08-05
- Regulation
- 886.5000
- Classification name
- Applicator, Negative Pressure, External, Ocular
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- 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#
Other 510(k) Records For Product Code QQJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230055 | FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System | Balance Ophthalmics, Inc. | 2024-06-27 |