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510(k) K252218

MF SC GEN2 Facial Toning System by Micro Current Technology, Inc. — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2025
Date Received
July 15, 2025
Clearance Type
Special
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.

  • K233095 — S21 OTC Transcutaneous Electrical Nerve Stimulator (March 1, 2024)
  • K233525 — MF SC Facial Toning System (November 24, 2023)
  • 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

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  • 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)
  • K244004 — Microcurrent Facial Device (CEC101, EE0101, EEI101) (July 10, 2025)
  • K250361 — SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 (May 23, 2025)