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510(k) Data Aggregation
K Number
K213039Device Name
Micro-current facial cold and hot service (model: TPML-100)
Manufacturer
Li-Tek Electronics Technology C0., Ltd
Date Cleared
2022-05-25
(245 days)
Product Code
OLP, NFO
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Li-Tek Electronics Technology C0., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for the over the counter aesthetic use.
Device Description
The Micro-current vibration facial cold and hot service device (Model: TPML-100) is a hand-held, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, and USB cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the USB cable. The device is un-usable when charging. The device is only home environment use, which has three metal heads (Dual / Single), and two LED light windows (Red / Blue) to provides following functions: a) EMS (micro current output stimulation) function. The device generates a low-frequency micro-current on the Dual Heads which will applied in the facial skin to do facial stimulation. b) Red and Blue LED irradiation function. The device outputs the red light at the wavelength of 630 ± 10 nm and the blue light at the wavelength of 415 ± 10 nm to apply the light in narrow spectral bandwidth on facial skin to treat mild to moderate acne. c) Vibration function. The device generates different patterns of micro-vibration by a builtin micro motor to relax the facial skin. (This function is classified as class I and not need for 510K.) d) Warming and Cooling function. The device heats Dual Heads up to 44 ± 2 °C or cool the Single Head down to 10 ± 2 °C, to relax the facial skin with a warm or cold sensation. (This function is not for medical purpose.)
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