510(k) K214078
- Device
- Silk?n Toothwave
- Applicant
- Home Skinovations , Ltd.
- 510(k) number
- K214078
- Product code
- QMJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-13
- Date received
- 2021-12-27
- Regulation
- 872.6866
- Classification name
- Powered Radiofrequency Toothbrush
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Amit Goren
- Address
- Tabor Bldg., Shaar Yokneam Yokneam IL 2069200 2069200
FDA Registration Numbers#
- 3027645761
Source Documents#
Other 510(k) Records For Product Code QMJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN190039 | ToothWave™ | Home Skinovations , Ltd. | 2020-09-17 |