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510(k) K182424

NuFACE FIX Skin Toning Device by Carol Cole Company Dba Nuface — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2018
Date Received
September 6, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Carol Cole Company Dba Nuface

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  • K191672 — NuFACE Mini Device (October 15, 2019)
  • K181008 — NuFACE Trinity (October 11, 2018)
  • K171588 — NuBODY Skin Toning Device (July 31, 2017)

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