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.

AI/ML Overview

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."

Summary

FDA 510(k) Clearance Letter - Microcurrent Facial Device

Page 1

July 10, 2025

Shenzhen Dachi communication Co.,Ltd.
℅ Jilan Luo
RA Specialist
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center,
No. 3101-90, Qianhai Road
Shenzhen, Guangdong 518052
China

Re: K244004
Trade/Device Name: Microcurrent Facial Device (CEC101, EE0101, EEI101)
Regulation Number: 21 CFR 882.5890
Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
Regulatory Class: Class II
Product Code: NFO
Dated: June 20, 2025
Received: June 20, 2025

Dear Jilan Luo:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K244004 - Jilan Luo Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K244004 - Jilan Luo Page 3

Sincerely,

Tushar Bansal -S

Tushar Bansal, PhD
Acting Assistant Director, Acute Injury Devices Team
DHT5B: Division of Neuromodulation and
Physical Medicine Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K244004

Device Name
Microcurrent Facial Device (CEC101, EE0101, EEI101)

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D) ☒ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Shenzhen Dachi communication Co.,Ltd. 510(k)s –510(k) Summary
Page 3 of 11

510(k) Summary of K244004

"510(k) Summary" as required by 21 CFR Part 807.92. Date: 2025-07-10

I. Submitter

Shenzhen Dachi communication Co.,Ltd.
Room 201，202，203，Building 3, Phase I, Huangtian Yangbei Industrial Zone, Huangtian Community, Hangcheng Street, Bao'an District, Shenzhen, China.
Post code: 518101
Tel.: +86 755 83142102

Xiao Chunhua
Title:SCM Manager
Tel.: +86 130 6873 9296
Email: pod@dachitel.com

II. Device

Name of Device: Microcurrent Facial Device
Model(s): CEC101, EE0101, EEI101
Common or Usual Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Classification Name: Transcutaneous electrical nerve stimulator for pain relief
Regulatory Class: II
Product Code: NFO
Regulation Number: 21 CFR 882.5890

III. Predicate Device

Predicate device:

Manufacturer	Predicate Device	510(k) Number	Cleared Date
BELEGA Co., Ltd.	BEAGANK 4T PLUS	K233010	November 21, 2023
Bio-Medical Research Ltd.	BMR Face	K103031	NOV 10, 2011

IV. Device Description

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

Page 6

Shenzhen Dachi communication Co.,Ltd. 510(k)s –510(k) Summary
Page 4 of 11

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.

V. Indications for Use

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.

VI. Comparison of Technological Characteristics With the Predicate Device

Microcurrent Facial Device is compared with the following Predicate Devices in terms of intended use, design, specifications, materials and performance: