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Multi-functional Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial stimulation through MC(micro-current) mode.

The Multi-functional Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

The device is only home environment use, which has some massage heads, and LED light mode (Red and /or Blue lights are output independently) to provides following functions.

a. Micro-current stimulation function.
b. Red LED irradiation function. (Cleared under K252142).
c. Blue LED irradiation.(Cleared under K252142).
d. Hot compress and vibration function.(The vibration is classified as class I and not need for 510K, and the hot compress(39℃±0.5℃) is not for medical purpose).
e. Hot compress function.(The hot compress(35.5℃～38.5±0.5℃) is not for medical purpose).
f. Vibration function(motor vibration).(The vibration is classified as class I and not need for 510K).

Each mode of the device is independent from all other modes of the Multi-functional Facial Beauty Device.

The Multi-functional Facial Beauty Device consists of a main unit, USB charging cable, components shown as following illustration: (Here takes model SKB-2109 and model SKB-2129 as examples)

SKB-2109:

• Intensity indicator
• Mode indicator
• Intensity button
• OFF/ON& Mode switch button
• Massage head
• LED light
• Massage head
• USB charging cable

SKB-2129:

• LEDs (Red)
• Massage head
• Power/Mode/Intensity Button
• RED LIGHT Indicator
• MC Indicator
• Intensity Indicator
• USB charging cable

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The Aura Glide is an over-the-counter handheld device for aesthetic purposes.
(1) The microcurrent mode is indicated for facial stimulation.
(2) The LED mode is intended for the treatment of periorbital wrinkles (red light) and for the treatment of mild to moderate inflammatory acne (blue light).

Aura Glide is a lemon shaped handheld device that consists of:

• A main control body that is programmed with preset treatment modes depending on the application at the time of use.
• Two (2) essential attachments that are detachable. Each attachment is specifically designed to sit securely on the main body to ensure proper functionality and stability during use.
  • LED (Light Emitting Diode) Attachment – intended for the treatment of periorbital wrinkles (red light) and for the treatment of mild to moderate acne (blue light).
  • Microcurrent Attachment – indicated for facial stimulation. Microcurrent can be delivered with three (3) levels of intensity; L1 (Gentle; Default), L2 (Standard), and L3 (Strong) depending on user preference.
• Conductive gel (Glide On Primer gel) must be applied prior to starting microcurrent treatment. It enhances conductivity ensuring safe and effective microcurrent treatment.
• The Aura Glide is equipped with a USB-C charging port located on the bottom of the device and an internal rechargeable battery. A USB-C charging cable is provided with every device.

The Aura Glide is an over-the-counter cosmetic device for home use.

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The Medi Lift Essential Eye Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.

The Medi Lift Essential Eye Mask ("Medi Lift Eye") is composed of a mask made of silicone rubber which is worn on the upper part of the user's face, and covers the upper cheek and the periocular region outside the orbital rim. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The mask also contains a heater to warm the upper cheek area for user relaxation, not for a medical purpose. The stimulation and heating functions are provided in separate modes and cannot be used simultaneously. The controllers attached to the mask contain two charging pins which allow for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable that is provided as part of the device. The device is not operated during charging.

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JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.

The JOVS Electric Stimulation Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It mainly consists of main unit, charging and disinfection base, and power cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging. The device is only home environment use, which has the spring electrode head (electric stimulation) to provide the following function:

The JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.

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Facial & Body Beauty Device is a hand-held device for over-the-counter aesthetic purposes.
The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.

Facial & Body Beauty Device is portable, non-sterile and reusable device, which is designed to achieve the aesthetic effect. The device mainly consists of a main unit and charging cable, and it is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the provided charging cable, but the device can not be used when charging. To use the device, user should place the electrode head on the face and body. The device will automatically shut down after treatment time is over.

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Low Frequency Electric Stimulator: This Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes.

The Sunny Plus device is a Low Frequency Electric Stimulator that conveys current to the human body through a non-invasive electrode with a frequency of 10Hz. It is composed of the main body, handpiece with electrode tip, and foot switch. The device is operated through a graphic user interface on an LCD screen and is intended to be operated by medical professionals.

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The SX2500 / SX3800 Series devices uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes.

The subject devices, SX2500 & SX3800, under the NFO Product Code, uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes. The SX series uses applied accessories like probes, gloves or pads to deliver low electrical current to stimulation of facial tissues for aesthetic purposes.

The SX2500 & SX3800 is a powered microcurrent stimulator that uses electrical energy to stimulate facial tissues for aesthetic purposes. The SX2500 & SX3800 is substantially equivalent to the predicate devices compared in its product code class and has the same IFU. The SX2500 & SX3800 delivers signals independently to specific facial area points by way of channel ports via stainless steel probes and applicators substantially equivalent to the predicate device. The probes, gloves and pads referenced are the only patient contacting parts on the device that is substantially equivalent to the predicate device.

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The MF SC GEN2 Facial Toning System is intended to stimulate the face. The device is intended for over the counter cosmetic use.

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The provided document is an FDA 510(k) clearance letter for the "MF SC GEN2 Facial Toning System." It confirms the device's substantial equivalence to legally marketed predicate devices for its stated indications for use.

Crucially, the document does NOT contain any information regarding acceptance criteria or a study proving the device meets these criteria.

This type of FDA letter is primarily a regulatory approval and does not detail the clinical or performance study data that the manufacturer submitted to support their 510(k) application. To provide the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.), one would need access to the actual 510(k) submission document itself, which is typically confidential business information and not released publicly by the FDA in detail.

Therefore,Based on the information provided in the FDA 510(k) clearance letter (K252218), it is not possible to describe the acceptance criteria and the study that proves the device meets these criteria.

The clearance letter primarily states that the device, "MF SC GEN2 Facial Toning System," is substantially equivalent to legally marketed predicate devices for its intended use (to stimulate the face, for over-the-counter cosmetic use). It does not contain the detailed performance data, study design, or acceptance criteria that would have been part of the manufacturer's 510(k) submission.

All sections of your request cannot be fulfilled as the necessary information is not present in the provided document.

To provide the requested details, one would need access to the full 510(k) submission document from Micro Current Technology, Inc., which is not publicly available in this correspondence.

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CEC101 and EE0101:
Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use.

EEI101:
Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use.

The Microcurrent Facial Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, membrane cloth, conductive gel and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

The provided FDA 510(k) clearance letter and summary for the Microcurrent Facial Device (K244004) does not contain information on acceptance criteria for a clinical study or a study proving the device meets performance criteria beyond safety and electrical standards.

This document primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons, safety testing (biocompatibility, electrical safety, EMC), and software verification/validation. It explicitly states that "The following performance data were provided in support of the substantial equivalence determination," and lists the aforementioned safety and software tests.

The listed "Indications for Use" for this device are for "facial stimulation for over-the-counter aesthetic use" and "facial, neck and body skin stimulation for over-the-counter aesthetic use." These are aesthetic claims, not medical claims requiring clinical efficacy studies in the same way a device for diagnosing or treating a disease would.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for clinical efficacy
• Sample size used for the test set and data provenance related to clinical efficacy
• Number of experts used to establish ground truth or their qualifications for clinical efficacy
• Adjudication method for a clinical test set
• MRMC comparative effectiveness study or effect size
• Standalone algorithm performance
• Type of ground truth used for clinical efficacy
• Sample size for the training set (for clinical efficacy)
• How ground truth for the training set was established (for clinical efficacy)

The document focuses solely on engineering and safety performance to demonstrate substantial equivalence, not clinical efficacy for aesthetic outcomes. The "performance data" section (Page 15) explicitly lists only biocompatibility, electrical safety, EMC, and software verification/validation as the bases for establishing substantial equivalence.

In summary, for K244004, the acceptance criteria and proof of meeting them are primarily related to safety and functional performance, not clinical efficacy for aesthetic outcomes, as it falls under the "Transcutaneous Electrical Nerve Stimulator For Pain Relief" product code (NFO) but is indicated for aesthetic use. The FDA clearance is based on the device being "as safe, as effective and performs as well as the legally marketed predicate devices" for its intended aesthetic stimulatory purpose, which is proven through the technical and safety evaluations outlined.

If this were an AI/ML medical device, the information requested would be crucial. However, for a microcurrent facial device, the regulatory pathway relies on different types of "performance data."

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