MF SC GEN2 Facial Toning System
FDA 510(k) K252218 · Micro Current Technology, Inc.
510(k) numberK252218
Submission
- Device name
- MF SC GEN2 Facial Toning System
- Applicant
- Micro Current Technology, Inc.
Seattle, WA, US - Received
- July 15, 2025
- Decision date
- July 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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| K252187 | Aura Glide (FC40)NFO · Traditional | Aura Medical, LLC | 12/23/2025SE |
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| K250618 | Medi Lift Essential Eye MaskNFO · Traditional | Ya-Man, Ltd. | 10/29/2025SE |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2)NFO · Traditional | Shenzhen Qianyu Technology Co., Ltd. | 10/17/2025SE |
More from Shenzhen Qianyu Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233095 | S21 OTC Transcutaneous Electrical Nerve StimulatorNUH · Traditional | 03/01/2024SE |
| K233525 | MF SC Facial Toning SystemNFO · Traditional | 11/24/2023SE |
| K183189 | Ultra OTC Facial Toning SystemNFO · Traditional | 04/17/2019SE |
| K181062 | Ultra Facial Toning SystemNFO · Traditional | 07/18/2018SE |
| K033253 | S21 Transcutaneous Electrical Nerve StimulatorGZJ · Traditional | 10/21/2003SE |
| K032653 | E275GZJ · Traditional | 09/12/2003SE |
| K993823 | MED-4000GZJ · Traditional | 11/19/1999SE |
Questions and answers
When was MF SC GEN2 Facial Toning System cleared by the FDA?
MF SC GEN2 Facial Toning System (K252218) received a 510(k) decision of Substantially Equivalent on July 18, 2025, 3 days after the submission was received.
What is the product code of K252218?
The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.