510(k) DEN230055
DEN230055 is an FDA 510(k) premarket notification submitted by Balance Ophthalmics, Inc. for the device "FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System". The FDA issued a decision of De Novo Granted on June 27, 2024. 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
- DENG (De Novo Granted)
- Decision Date
- June 27, 2024
- Date Received
- August 25, 2023
- Clearance Type
- Direct
- 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.