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510(k) K171588

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2017
Date Received
May 31, 2017
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

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  • K191672 — NuFACE Mini Device (October 15, 2019)
  • K182424 — NuFACE FIX Skin Toning Device (December 18, 2018)
  • K181008 — NuFACE Trinity (October 11, 2018)

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