NEWA Kit 1.5, Ivory
NEWA Kit 1.5, Ivory (ND_PRD00126) is a home-use radio-frequency skin contouring unit (FDA Class II; FDA product code PAY, Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction) made by Endymed Medical Ltd, granted FDA De Novo DEN150005 on 18 Dec 2015 and listed in FDA GUDID since 30 Sep 2018 (UDI-DI 07290014660007), active as of 23 Oct 2026.
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290014660007 | Date30 Sep 2018 | StatusListed |
| United States | FDA De NovoDENG | NumberDEN150005 | Date18 Dec 2015 | StatusActive |
Official records
- AccessGUDID record 07290014660007
- FDA De Novo database DEN150005
Across registries
- FDA De Novo DEN150005 decided 18 Dec 2015 Active
- FDA GUDID UDI-DI 07290014660007 listed 30 Sep 2018 Listed
Timeline
- Granted FDA De Novo DEN150005
- Listed FDA GUDID 07290014660007
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Trade name
- NEWA Kit
- Generic name
- Home-use radio-frequency skin contouring unit
- Model / Ref / Catalog
- 1.5, Ivory, ND_PRD00126
- Primary DI / UDI-DI
- 07290014660007
- De Novo Number
- FDA product code
- PAY
- GMDN term
- Home-use radio-frequency skin contouring unit
- Device class
- Class II
- Regulation number
- 878.4420
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).