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510(k) K233525

MF SC Facial Toning System by Micro Current Technology, Inc. — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2023
Date Received
November 1, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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)
  • K183189 — Ultra OTC Facial Toning System (April 17, 2019)
  • 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

  • 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)