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510(k) K201906

Trinity ELE Plus and Trinity ELE Plus Pro by Carol Cole Company Dba Nuface — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2021
Date Received
July 9, 2020
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

  • K212947 — Trinity Plus Wrinkle Reducer (April 2, 2022)
  • K201782 — NuFace Trinity Plus Device (January 22, 2021)
  • K191672 — NuFACE Mini Device (October 15, 2019)
  • K182424 — NuFACE FIX Skin Toning Device (December 18, 2018)
  • K181008 — NuFACE Trinity (October 11, 2018)
  • K171588 — NuBODY Skin Toning Device (July 31, 2017)

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