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510(k) K183189

Ultra OTC Facial Toning System by Micro Current Technology, Inc. — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2019
Date Received
November 19, 2018
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 Micro Current Technology, Inc.

  • K252218 — MF SC GEN2 Facial Toning System (July 18, 2025)
  • K233095 — S21 OTC Transcutaneous Electrical Nerve Stimulator (March 1, 2024)
  • K233525 — MF SC Facial Toning System (November 24, 2023)
  • K181062 — Ultra Facial Toning System (July 18, 2018)
  • K033253 — S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (October 21, 2003)
  • K032653 — E275 (September 12, 2003)
  • K993823 — MED-4000 (November 19, 1999)

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)