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K Number
K233525
Device Name
MF SC Facial Toning System
Manufacturer
Micro Current Technology, Inc.
Date Cleared
2023-11-24

(23 days)

Product Code
NFO
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MF SC Facial Toning System is intended to stimulate the face. The device is indicated for over the counter cosmetic use.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "MF SC Facial Toning System." The document is an FDA 510(k) clearance letter, which primarily addresses regulatory aspects like substantial equivalence to predicate devices and adherence to general controls provisions. It does not include details about specific performance studies or their results.

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).