Home / 510(k) Clearances / K103472

510(k) K103472

NUFACE PLUS by Carol Cole Company — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2011
Date Received
November 24, 2010
Clearance Type
Abbreviated
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

  • K161654 — NuFACE Gel Primer (December 30, 2016)
  • K133823 — NUFACE MINI DEVICE (April 17, 2014)
  • K131251 — TRINITY ELE (October 1, 2013)
  • K120560 — TRINITY WRINKLE REMOVER (November 6, 2012)
  • K072260 — NUFACE, MODEL NU-4003 (November 27, 2007)

Other clearances for product code NFO

  • K252187 — Aura Glide (FC40) (December 23, 2025)
  • K252146 — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB (December 23, 2025)
  • K250618 — Medi Lift Essential Eye Mask (October 29, 2025)
  • K250227 — JOVS Electric Stimulation Beauty Device (JE2) (October 17, 2025)
  • K251034 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare (October 12, 2025)
  • K252553 — Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C (October 9, 2025)
  • K251649 — Sunny Plus (Sunny) (September 18, 2025)
  • K251909 — NeurotriS (SX2500); NeurotriS (SX3800) (September 3, 2025)
  • K252218 — MF SC GEN2 Facial Toning System (July 18, 2025)
  • K244004 — Microcurrent Facial Device (CEC101, EE0101, EEI101) (July 10, 2025)