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510(k) K131870

GLIDE DEVICE by Home Skinovations , Ltd. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2013
Date Received
June 24, 2013
Clearance Type
Special
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.

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  • 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)
  • K121435 — SILKN BLUE (February 22, 2013)
  • K120582 — HEATLUX (July 6, 2012)

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