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K Number
K181062
Device Name
Ultra Facial Toning System
Manufacturer
Micro Current Technology, Inc.
Date Cleared
2018-07-18

(86 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 Ultra Facial Toning System is intended to stimulate the face. The device is intended for cosmetic use.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Ultra Facial Toning System." It is a regulatory document addressing the substantial equivalence of the device to existing predicate devices. It does not contain any information about acceptance criteria or the study that proves the device meets those criteria.

Specifically, the document:

  • Confirms K181062 as the premarket notification number.
  • States the Trade/Device Name: Ultra Facial Toning System.
  • Identifies the Regulation Number and Name for Transcutaneous Electrical Nerve Stimulator For Pain Relief.
  • Classifies the device as Class II with Product Code NFO.
  • Declares the device substantially equivalent for its stated indications for use.
  • Outlines general controls provisions and other regulatory requirements.
  • Provides contact information for various FDA departments.
  • Details the "Indications for Use" which states: "The Ultra Facial Toning System is intended to stimulate the face. The device is intended for cosmetic use."
  • Notes it is a Prescription Use device.

Therefore, it is not possible to describe acceptance criteria or a study proving the device meets them based on the provided text, as this information is not present in the document.

§ 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).