510(k) K252455
K252455 is an FDA 510(k) premarket notification submitted by Balance Ophthalmics, Inc. for the device "FSYX Ocular Pressure Adjusting Pump". The FDA issued a decision of Substantially Equivalent on Apr 30, 2026. The device falls under product code QQJ (Applicator, Negative Pressure, External, Ocular), a Class II device regulated under 21 CFR 886.5000. Balance Ophthalmics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 30, 2026
- Date Received
- Aug 5, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Negative Pressure, External, Ocular
- Device Class
- Class II
- Regulation Number
- 886.5000
- Review Panel
- OP
- Submission Type
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.