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Li-Tek Electronic Technology Corporation

3 FDA records filed under this company name, from 2017, in microcurrent and ems (NFO, 2), light for acne (OLP, 1).

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

Electrical stimulation for aesthetic use (microcurrent and EMS) (NFO, 2)

510(k) cleared

Smart Photon Micro-current Device, Model: EP-300

510(k) number
K162652
Applicant
Li-Tek Electronic Technology Corporation
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use. For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles, For blue light irradiation mode: The blue light is for the treatment of mild to moderate acne.”

Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

Micro-current Wrinkle Reduction Facial service, model EP-400

510(k) number
K162106
Applicant
Li-Tek Electronic Technology Corporation
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The device is intended for facial stimulation by electrode heads for cosmetic use. The device is also intended for the treatment of periorbital wrinkles with red Light Emitting Diode (LED) head. It is for over-the-counter use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

LED and light devices for acne (OLP, 1)

510(k) cleared

LED Phototherapy Device

510(k) number
K162098
Applicant
Li-Tek Electronic Technology Corporation
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

FDA database recordFDA document (PDF)