Identifiers
- 510(k) Number
- K233525 FDA 510(k)
- FDA Product Code
- NFO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MF SC Facial Toning System is a transcutaneous electrical stimulator for aesthetic purposes. It is a Class II device that uses microcurrent technology to provide facial toning.
The device is manufactured by Micro Current Technology, Inc. and received FDA 510(k) clearance on November 24, 2023. It is regulated under product code NFO and regulation number 882.5890. The device is intended for aesthetic purposes and reviewed by the Neurology advisory committee.
Frequently asked questions
What is the MF SC Facial Toning System used for?
The MF SC Facial Toning System is a transcutaneous electrical stimulator designed for aesthetic purposes. It uses microcurrent technology to provide facial toning treatments, helping to improve the appearance of facial muscles and skin.
Is the MF SC Facial Toning System a single-use or reusable device?
The device is designed for multiple uses as it is a transcutaneous electrical stimulator. It should be properly maintained and cleaned according to the manufacturer's instructions between treatments to ensure safety and effectiveness.
What regulatory approvals does the MF SC Facial Toning System have?
The MF SC Facial Toning System received FDA 510(k) clearance on November 24, 2023. It is classified as a Class II device under product code NFO and regulation number 882.5890, and was reviewed by the Neurology advisory committee.
How is the MF SC Facial Toning System supplied?
The device is manufactured by Micro Current Technology, Inc. in Seattle, Washington. It includes the main stimulator unit and necessary components for facial toning procedures, though specific accessories and packaging details would be included with the product.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MF SC Facial Toning System - SkinCarisma, MF SC GEN2 Facial Toning System - skincarisma.com, MF SC Facial Toning System 510 (k) K233525 - FDA.report, K233525 FDA 510 (k) - MF SC Facial Toning System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233525 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro Current Technology, Inc.
Sources (1)
- FDA 510(k) K233525 24 fields · synced Sep 26, 2026