510(k) K214078
K214078 is an FDA 510(k) premarket notification submitted by Home Skinovations , Ltd. for the device "Silkn Toothwave". The FDA issued a decision of Substantially Equivalent on January 13, 2023. 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
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2023
- Date Received
- December 27, 2021
- Clearance Type
- Traditional
- 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.