510(k) DEN190039
- Device
- ToothWave™
- Applicant
- Home Skinovations , Ltd.
- 510(k) number
- DEN190039
- Product code
- QMJ
- Decision
- Unknown (DENG)
- Decision date
- 2020-09-17
- Date received
- 2019-08-22
- Regulation
- 872.6866
- Classification name
- Powered Radiofrequency Toothbrush
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Amit Goren
- Address
- Tabor Bldg., Shaar Yokneam Yokneam IL 2069200 2069200
FDA Registration Numbers#
- 3027645761
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QMJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K214078 | Silk’n Toothwave | Home Skinovations , Ltd. | 2023-01-13 |