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Myolift QT

by Johari Digital Healthcare, Ltd.

510(k) K213078

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213078 Date27 Apr 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NFO
FDA applicant
Johari Digital Healthcare Limited
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Myolift QT is a transcutaneous electrical stimulator for aesthetic purposes. It uses micro-current technology to deliver gentle, non-invasive electrical impulses to facial muscles through two applicator probes, re-educating and strengthening the muscles.

The device is supplied as a personal facial toning device and is intended for use on the face and neck. It is a Class II medical device with FDA 510(k) clearance (K213078) and is manufactured by Johari Digital Healthcare Ltd. in India.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Myolift QT used for?

    The Myolift QT is used for aesthetic purposes, specifically for facial toning and strengthening facial muscles through gentle, non-invasive electrical impulses.

  • Is the Myolift QT a single-use device?

    The description does not explicitly state that the Myolift QT is single-use, suggesting it may be reusable as a personal facial toning device.

  • What kind of clearance does the Myolift QT have?

    The Myolift QT has FDA 510(k) clearance, indicated by the clearance number K213078, which signifies it is substantially equivalent to a predicate device.

  • How is the Myolift QT supplied?

    The Myolift QT is supplied as a personal facial toning device, intended for use on the face and neck, and comes with two applicator probes.