Microcurrent Facial Device (CEC101, EE0101, EEI101)

FDA 510(k) K244004 · Shenzhen Dachi Communication Co., Ltd.

Substantially Equivalent

510(k) numberK244004

Submission

Device name
Microcurrent Facial Device (CEC101, EE0101, EEI101)
Applicant
Shenzhen Dachi Communication Co., Ltd.
Shenzhen, CN
Received
December 26, 2024
Decision date
July 10, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

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More from Shenzhen Qianyu Technology Co., Ltd.

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Questions and answers

When was Microcurrent Facial Device (CEC101, EE0101, EEI101) cleared by the FDA?

Microcurrent Facial Device (CEC101, EE0101, EEI101) (K244004) received a 510(k) decision of Substantially Equivalent on July 10, 2025, 196 days after the submission was received.

What is the product code of K244004?

The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.