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510(k) K181008

NuFACE Trinity by Carol Cole Company Dba Nuface — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2018
Date Received
April 17, 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

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  • K191672 — NuFACE Mini Device (October 15, 2019)
  • K182424 — NuFACE FIX Skin Toning Device (December 18, 2018)
  • K171588 — NuBODY Skin Toning Device (July 31, 2017)

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