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510(k) K214078

Silk’n Toothwave by Home Skinovations , Ltd. — Product Code QMJ

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.

Other clearances by Home Skinovations , Ltd.

  • DEN190039 — ToothWave™ (September 17, 2020)
  • K180279 — Silk'n MODEL H5003 device (May 9, 2018)
  • K171433 — Silk'n Infinity (August 11, 2017)
  • K162784 — Silk'n HST (March 25, 2017)
  • K152087 — HeatLux Pro II (July 29, 2016)
  • K150175 — HeatLux Pro I (March 31, 2015)
  • K141242 — GLIDE DEVICE (October 17, 2014)
  • K131870 — GLIDE DEVICE (August 14, 2013)
  • K121435 — SILKN BLUE (February 22, 2013)
  • K120582 — HEATLUX (July 6, 2012)

Other clearances for product code QMJ

  • DEN190039 — ToothWave™ (September 17, 2020)