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510(k) DEN190039

ToothWave™ by Home Skinovations , Ltd. — Product Code QMJ

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.

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  • K152087 — HeatLux Pro II (July 29, 2016)
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  • K141242 — GLIDE DEVICE (October 17, 2014)
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Other clearances for product code QMJ

  • K214078 — Silk’n Toothwave (January 13, 2023)