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510(k) K171433

Silk'n Infinity by Home Skinovations , Ltd. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2017
Date Received
May 15, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Over-The-Counter Hair Removal
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

Over-the-counter device uses thermal energy to kill hair follicles for hair removal.

Other clearances by Home Skinovations , Ltd.

  • K214078 — Silk’n Toothwave (January 13, 2023)
  • DEN190039 — ToothWave™ (September 17, 2020)
  • K180279 — Silk'n MODEL H5003 device (May 9, 2018)
  • 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)

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