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De Novo DEN150005
- Device
- Newa Skin Therapy System
- Contact
- yoram levy
- De Novo number
- DEN150005
- Product code
- PAY
- Regulation
- 878.4420
- Classification name
- over-the-counter radiofrequency coagulation device for wrinkle reduction
- Decision
- granted (DENG)
- Decision date
- 2015-12-18
- Date received
- 2015-01-16
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- PAY
- Device name
- Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4420
- Implant
- N
- Life sustain/support
- N