De Novo DEN230055
- Device
- FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System
- Contact
- gary mocnik
- De Novo number
- DEN230055
- Product code
- QQJ
- Regulation
- 886.5000
- Classification name
- applicator, negative pressure, external, ocular
- Decision
- granted (DENG)
- Decision date
- 2024-06-27
- Date received
- 2023-08-25
- Classification advisory
- Ophthalmic
- Review advisory
- Ophthalmic
- Type
- Direct
Current FDA Classification#
- Product code
- QQJ
- Device name
- Applicator, Negative Pressure, External, Ocular
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation
- 886.5000
- Implant
- N
- Life sustain/support
- N