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510(k) K161654

NuFACE Gel Primer by Carol Cole Company — Product Code GYB

K161654 is an FDA 510(k) premarket notification submitted by Carol Cole Company for the device "NuFACE Gel Primer". The FDA issued a decision of Substantially Equivalent on December 30, 2016. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Carol Cole Company has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2016
Date Received
June 15, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

Other clearances by Carol Cole Company

  • K133823 — NUFACE MINI DEVICE (April 17, 2014)
  • K131251 — TRINITY ELE (October 1, 2013)
  • K120560 — TRINITY WRINKLE REMOVER (November 6, 2012)
  • K103472 — NUFACE PLUS (November 7, 2011)
  • K072260 — NUFACE, MODEL NU-4003 (November 27, 2007)

Other clearances for product code GYB

  • K243749 — Jmoon Conductive Gel (April 8, 2025)
  • K220735 — Avologi Gel Primer (Model: Av25) (September 15, 2023)
  • K222770 — Conductive Gel (December 13, 2022)
  • K221724 — Conductive Gel (September 23, 2022)
  • K212325 — EEG-acp (June 15, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K212787 — GT5 conductive & abrasive gel (November 8, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K191975 — Elefix V Paste for EEG & EMG (February 7, 2020)
  • K192606 — SAC2 - Electrode Cream (January 17, 2020)

FDA data resources