510(k) DEN190039
DEN190039 is an FDA 510(k) premarket notification submitted by Home Skinovations , Ltd. for the device "ToothWave". The FDA issued a decision of De Novo Granted on September 17, 2020. The device falls under product code QMJ (Powered Radiofrequency Toothbrush), a Class II device regulated under 21 CFR 872.6866. Home Skinovations , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 17, 2020
- Date Received
- August 22, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powered Radiofrequency Toothbrush
- Device Class
- Class II
- Regulation Number
- 872.6866
- Review Panel
- DE
- Submission Type
A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.