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510(k) K191672

NuFACE Mini Device by Carol Cole Company Dba Nuface — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2019
Date Received
June 24, 2019
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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  • K181008 — NuFACE Trinity (October 11, 2018)
  • K171588 — NuBODY Skin Toning Device (July 31, 2017)

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