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Found 67 results
510(k) Data Aggregation
K Number
K252218Device Name
MF SC GEN2 Facial Toning System
Manufacturer
Micro Current Technology, Inc.
Date Cleared
2025-07-18
(3 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Product Code :
NFO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K244004Device Name
Microcurrent Facial Device (CEC101, EE0101, EEI101)
Manufacturer
Shenzhen Dachi communication Co.,Ltd.
Date Cleared
2025-07-10
(196 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Product Code :
NFO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K250361Device Name
SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
Manufacturer
GESKE Beauty Tech GmbH
Date Cleared
2025-05-23
(102 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Product Code :
NFO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
Device Description
SmartAppGuided™ MicroCurrent Face-Lift Pen| 6 in 1 is an over-the-counter stimulation device. Its enclosure is injection-molded thermoplastic resin with silicone embedded in it. The output contacts consist of an electrode composed of chrome-plated or titanium- gold plated sphere. The device is powered by a rechargeable lithium-ion battery and cannot be used while charging. The device produces microcurrent that is discharged through two fixed, smooth spherical electrodes, and it has 3 current intensity levels that can be adjusted by pressing the on/off button on the device. Press the on/off button to turn on the device, and two spherical electrodes provide low-level electrical pulses to the target position of the face, and when the EMS function is turned on, the vibration function is also turned on simultaneously; The device spheres are designed for optimal contact with facial skin. The device delivers microcurrent as a constant biphasic square wave comprised of 10 positive pulses followed by 10 negative pulses. The microcurrent output continuously alternates between the positive and negative spherical electrodes.
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K Number
K243072Device Name
Préime DermaFacial (MicroT)
Manufacturer
EMA Aesthetics, LTD
Date Cleared
2025-04-01
(186 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Product Code :
NFO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Préime DermaFacial with MicroT Applicator is intended to stimulate facial tissues for aesthetic purposes in the face.
Device Description
Not Found
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K Number
K243587Device Name
PureLift GLOW
Manufacturer
Xtreem Pulse LLC
Date Cleared
2025-03-06
(106 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Product Code :
NFO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PureLift GLOW is intended for facial and neck stimulation, treatment of wrinkles, treatment of mild to moderate inflammatory acne, and indicated for over-the-counter cosmetic use.
Device Description
PureLift GLOW is a hand-held device intended to apply electrical impulses to strategic locations on the face and Light Emitting Diode (LED) technology that is intended for the treatment of wrinkles and mild to moderate inflammatory acne. The PureLift GLOW probes are designed for optimal contact with the LED technology is not intended to come into contact with the user. The device continually alternates between the positive probes and allows the user to adjust the settings for personalized comfort level by pressing the intensity starts at (1) and continues to (10). The LED treatment area is approximately 36.3cm2 and available five levels of blue (465nm) and red (634nm) wavelengths. The device housing is injection molded of biocompatible thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt rechargeable battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pressed, and a green light illuminates to indicate that the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level to strategic locations on the face and neck with the use of a conductive gel and the LED light is directed to the treatment area.
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K Number
K243063Device Name
Myolight Microcurrent Handpiece
Manufacturer
Raja Trading Company, Inc.
Date Cleared
2025-02-10
(136 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Product Code :
NFO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.
Device Description
The subject device, the MyoLight Microcurrent Handpieces are intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the device. There are two MyoLight Microcurrent Handpieces that connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body. The handpieces are different in dimensions but not function. The handpieces contain the electrodes that deliver microcurrent for aesthetic use. The subject device is intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the handpieces. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about therapy type, remaining therapy time and main therapy parameters on the screen.
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K Number
K243393Device Name
JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)
Manufacturer
Shenzhen Ulike Smart Electronics Co., Ltd.
Date Cleared
2025-02-03
(95 days)
Product Code
NFO, OHS
Regulation Number
882.5890Why did this record match?
Product Code :
NFO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JMOON NouvelleSkin facial toning device is intended for facial stimulation and indicated for overthe-counter cosmetic use.
JMOON NouvelleSkin facial toning device is an over-the-counter device that emits energy in the red and near-infrared spectrum, designed for the treatment of facial wrinkles.
Device Description
Jmoon NouvelleSkin Facial Toning device is an at-home handled device that provides an advanced, easy-to-use and efficient solution for better facial wellness. This device includes microcurrent, red and infra-red light LED, which allow you to customize your treatments according to your face skin. The device provides indicator lights and beeps feedback to guide the user during the treatment cycle.
The microcurrent therapy will deliver 3 different low-level electrical microcurrent impulses on face within a few minutes to complete facial stimulation. The red light and infra-red therapy is a treatment that uses red light to reportedly improve your skin's appearance, like reducing wrinkles.
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K Number
K244048Device Name
Medi Lift Mask
Manufacturer
YA-MAN Ltd
Date Cleared
2025-01-16
(16 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Product Code :
NFO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Device Description
The Medi Lift Mask is composed of a mask made of silicone rubber which is worn on the lower part of the user's face, and covers the user's cheeks and nose. 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 controllers attached to the mask contain two charging pins which allows for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable and an adapter that is provided as part of the device is not operated during charging.
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K Number
K243430Device Name
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
Manufacturer
Shenzhen Aozemei Technology Co. Ltd
Date Cleared
2024-12-19
(44 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Product Code :
NFO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718)
Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation.
Device Description
The Micro-current Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, cleaning flannelette, storage bag, instrument base 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 two massage heads, and three LED light mode (Amber/ Red/ Blue lights are output independently) to provides following functions:
a. Amber, Red and Blue LED irradiation function. The device outputs amber light with the wavelength of 605±10nm, and red light with the wavelength of 630±10mm. It is used to illuminate facial skin with narrow spectral bandwidth light and treat facial wrinkles. Also, it outputs blue light with the wavelength of 415±10nm and is used to illuminate facial skin with narrow spectral bandwidth light and treat mild to moderate inflammatory acne. (Cleared under K241718)
b. Hot compress and vibration function. The device generates different intensity of vibration by a builtin motor to relax the facial skin, and also, the massage head is heated to 40±1℃, making the facial skin feel warm to relax and soothe the facial skin. (The vibration is classified as class I and not need for 510K, and the hot compress is not for medical purpose). (Cleared under K241718)
c. MS-Micro current stimulation function. The device has two electrode massage heads to do facial stimulation.
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K Number
K242532Device Name
BTL-785BNF-E
Manufacturer
BTL Industries, Inc.
Date Cleared
2024-12-13
(109 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Product Code :
NFO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for aesthetic use including facial and neck or body skin stimulation.
Device Description
The BTL-785BNF-E is a state-of-the-art electrostimulation device that enables the application of therapy by electrical stimulation to patient's skin for aesthetic use. The main control unit is equipped with a large color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, the remaining therapy time and the main therapy parameters on the screen. The generated electrical stimulation is intenact with the tissues of the human body in order to achieve skin stimulation in the face. The device consists of the following main components: BTL-785 main unit, BTL-785-7 Handpiece, Single-use application electrodes, Holding arm, Connection cables, Therapy discomfort button.
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