Home / 510(k) Clearances / K072260

510(k) K072260

NUFACE, MODEL NU-4003 by Carol Cole Company — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2007
Date Received
August 14, 2007
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

  • 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)
  • K103472 — NUFACE PLUS (November 7, 2011)

Other clearances for product code NFO

  • K252146 — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB (December 23, 2025)
  • K252187 — Aura Glide (FC40) (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)