FSYX Ocular Pressure Adjusting Pump
FDA 510(k) clearance K252455 · decided 2026-04-30
Clearance details
- K-number
- K252455
- Device name
- FSYX Ocular Pressure Adjusting Pump
- Applicant
- Balance Ophthalmics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-05
- Decision date
- 2026-04-30
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- QQJ
- Device class
- 2
- Regulation number
- 886.5000
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Sioux Falls, SD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System (DEN230055) | Balance Ophthalmics, Inc. | 2024-06-27 |
Recalls involving this device
No recalls on record reference this clearance.