FSYX Ocular Pressure Adjusting Pump— 510(k) K252455
Substantially EquivalentBalance Ophthalmics, Inc.
FDA 510(k) clearance K252455 for FSYX Ocular Pressure Adjusting Pump, Substantially Equivalent on 2026-04-30. Applicant: Balance Ophthalmics, Inc.. Device class: 2.
Summary
Balance Ophthalmics' FSYX Ocular Pressure Adjusting Pump is filed under product code QQJ (Applicator, Negative Pressure, External, Ocular).
Class II, 21 CFR 886.5000. Ophthalmic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Balance Ophthalmics filed from Sioux Falls, South Dakota. The decision came 268 calendar days after FDA received it (August 5, 2025 to April 30, 2026).
Clearance details
- Applicant
- Balance Ophthalmics, Inc.
- Product code
- Product code QQJ
- Device class
- Class 2
- Regulation
- 21 CFR 886.5000
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sioux Falls, SD, US
Recent devices under product code QQJ
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