Microcurrent Facial Device (CEC101, EEI101)

K252642 · Shenzhen Dachi Communication Co., Ltd. · OHS · Nov 19, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K252642
• Device Name: Microcurrent Facial Device (CEC101, EEI101)
• Applicant: Shenzhen Dachi Communication Co., Ltd.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Nov 19, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CEC101: Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use. The light treatment of Microcurrent Facial Device is indicated for : - Red light is intended for the treatment of facial wrinkles. - Blue light is intended for the treatment of mild to moderate inflammatory acne. EEI101: Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use. The light treatment of Microcurrent Facial Device is indicated for: - Red light is intended for the treatment of facial wrinkles. - Blue light is intended for the treatment of mild to moderate inflammatory acne. - Mixed light (Red and Blue) is intended for the treatment of mild to moderate inflammatory acne.

Device Story

Microcurrent Facial Device (models CEC101, EEI101) provides facial/neck/body skin stimulation and LED light therapy. Device features stainless steel probe for skin contact and LED arrays (blue 415nm, red 622nm). User selects modes via button; intensity adjustable (0-9). CEC101 includes phototherapy, cleaning, penetration, lifting, and cool modes; EEI101 includes phototherapy, face, neck, and body modes. Device operates on internal rechargeable lithium-ion battery. Intended for OTC home use by consumers. Output provides aesthetic stimulation and light-based treatment for wrinkles and acne. Healthcare providers do not operate device; output is used by patient for self-care. Benefits include improved skin appearance and acne management.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation). Electrical safety and EMC testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471, and IEC 62133-2. Software verification and validation performed.

Technological Characteristics

Materials: Medical-grade biocompatible plastic enclosure, stainless steel probe. Energy: Rechargeable lithium-ion battery (3.7V/2600mAh). Light source: LEDs (Blue 415±10nm, Red 622±10nm). Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471, IEC 62133-2, ISO 10993-5/10/23.

Indications for Use

Indicated for OTC aesthetic facial stimulation (CEC101) or facial, neck, and body skin stimulation (EEI101). Red light indicated for facial wrinkles; blue light for mild to moderate inflammatory acne; mixed light (EEI101 only) for mild to moderate inflammatory acne.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Micro-current Facial Beauty Device (AM-810W, AM-810B, AM-812W, AM-812B) (K241718)
• BEMER Therapy Systems Evo (B.Light Clear Evo and B.Light Restore Evo) (K223919)

Reference Devices

• Led Mask Platinum Exclusive MD (K232795)
• LED Therapy Mask (MN1, M226) (K242385)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

November 19, 2025

Shenzhen Dachi communication Co., Ltd.
% Bing Huang
Registration Engineer
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center,
No. 3101-90 Qianhai Road
Shenzhen, Guangdong 518052
China

Re: K252642
Trade/Device Name: Microcurrent Facial Device (CEC101, EEI101)
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: OHS
Dated: August 21, 2025
Received: August 21, 2025

Dear Bing Huang:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252642 - Bing Huang
Page 2

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" (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.

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K252642 - Bing Huang
Page 3

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

TANISHA L. HITHE - S
Digitally signed by
TANISHA L. HITHE -
Date: 2025.11.19
14:46:04 -05'00'

Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252642 | |
| Device Name Microcurrent Facial Device (CEC101, EEI101) | |
| Indications for Use (Describe) EC101: Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use. The light treatment of Microcurrent Facial Device is indicated for : - Red light is intended for the treatment of facial wrinkles. - Blue light is intended for the treatment of mild to moderate inflammatory acne. EEI101: Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use. The light treatment of Microcurrent Facial Device is indicated for: - Red light is intended for the treatment of facial wrinkles. - Blue light is intended for the treatment of mild to moderate inflammatory acne. - Mixed light (Red and Blue) is intended for the treatment of mild to moderate inflammatory acne. | |
| 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 [e-mail] | |
| "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

# 510(k) Summary #K252642

"510(k) Summary" as required by 21 CFR Part 807.92.

Date: 2025-11-19

## 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.: [phone]

Xiao Chunhua
Title: SCM Manager
Tel.: [phone]
Email: [e-mail]

## II. Device

Name of Device: Microcurrent Facial Device
Model(s): CEC101, EEI101
Common or Usual Name: Light Based Over The Counter Wrinkle Reduction Over-The Counter Powered Light Based Laser For Acne
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Product Code: OHS, OLP
Regulation Number: 21 CFR 890.4810

## III. Predicate Device

Predicate device:

| Manufacturer | Predicate Device | 510(k) Number | Cleared Date |
| --- | --- | --- | --- |
| Shenzhen Aozemei Technology Co., LTD | Micro-current Facial Beauty Device(Model(s): AM-810W, AM-810B, AM-812W, AM-812B) | K241718 | October 28, 2024 |
| BEMER Int. AG | BEMER Therapy Systems Evo(B.Light Clear Evo and B.Light Restore Evo) | K223919 | September 23, 2023 |

Reference device:

| Manufacturer | Predicate Device | 510(k) Number | Cleared Date |
| --- | --- | --- | --- |
| STG24 CO.,LTD. | Led Mask Platinum Exclusive MD | K232795 | December 7, 2023 |

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Shenzhen Dachi communication Co.,Ltd.

510(k)s -510(k) Summary

| SHENZHEN
BORRIA
TECHNOLOGY
CO.,LTD | LED Therapy Mask (MN1, M226) | K242385 | April 7, 2025 |
| --- | --- | --- | --- |

## IV. Device Description

The Microcurrent Facial Device probe is designed for optimal contact with the face. The device has two different microcurrent modes that differ in how the probe switches. Users can adjust settings for personalized comfort by pressing the mode button. The microcurrent mode intensity starts from (0) to (9).(Cleared under K244004)

The device also outputs blue light with the wavelength of 415+/-10nm and red light with the wavelength 622+/-10nm and delivers to the skin of the face to achieve the therapeutic effects, such as improving mild to moderate acne on the face.

The Microcurrent Facial Devices unit contains a main board and a rechargeable battery. The enclosure is made of medical-grade biocompatible plastic and the probe is made of irregularly shaped stainless steel.

Model CEC101 have “Phototherapy mode”, “CLEANING mode”, “PENETRATION mode”, “LIFTING mode” and “COOL mode” five modes. The “CLEANING mode”, “PENETRATION mode”, “LIFTING mode” and “COOL mode” modes have cleared under K244004.

Model EEI101 have “Phototherapy mode”, “Face mode”, “Neck mode”, and “Body mode” four modes. The “Face mode”, “Neck mode”, and “Body mode” have cleared under K244004.

## V. Indications for Use

### CEC101:

Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use.

The light treatment of Microcurrent Facial Device is indicated for :

- Red light is intended for the treatment of facial wrinkles.
- Blue light is intended for the treatment of mild to moderate inflammatory acne.

### EEI101:

Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use.

The light treatment of Microcurrent Facial Device is indicated for:

- Red light is intended for the treatment of facial wrinkles.
- Blue light is intended for the treatment of mild to moderate inflammatory acne.
- Mixed light (Red and Blue) is intended for the treatment of mild to moderate inflammatory acne.

## VI. Comparison of Technological Characteristics With the Predicate Device

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

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Shenzhen Dachi communication Co., Ltd.
510(k)s -510(k) Summary

| Comparison Elements | Subject Device | Predicate device 1 | Predicate device 2 | Reference device1 | Reference device 2 | Remark |
| --- | --- | --- | --- | --- | --- | --- |
| K number | K252642 | K241718 | K223919 | K232795 | K242385 | / |
| Trade name/Model | Microcurrent
Facial Device
Models: CEC101, EEI101 | Micro-current Facial Beauty Device
Model: AM-810B, AM-810W, AM-812B, AM-812W | BEMER Light Therapy System(B. Light Clear Evo, B.light Restore Evo) | LED MASK EXCLUSIVE MD(Model:ME-M20M4) | LED Therapy Mask (MN1, M226) | / |
| Manufacturer | Shenzhen Dachi Communication Co., Ltd.. | Shenzhen Aozemei Technology Co., LTD | BEMER International, AG | STG24 CO.,LTD. | SHENZHEN BORRIA TECHNOLOGY CO.,LTD | / |
| Device Classification Name | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology | Same |
| Review panel | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | Same |
| Regulation number | 878.4810 | 878.4810 | 878.4810 | 878.4810 | 878.4810 | Same |
| Device class | II | II | II | II | II | Same |
| Product code | OHS, OLP | OHS, OLP | OHS/OLP | OLP | OHS, OLP, ILY | Same |
| Indication for use/Intended use | CEC101: The light treatment of Microcurrent Facial Device is indicated for :
• Red light is intended for the treatment of facial | Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. | B.Light Clear Evo: The device is intended for over-the-counter (OTC) use to treat patients with mild to moderate acne vulgaris on the face.
B.Light Restore Evo: Use | LED MASK EXCLUSIVE MD is an over the counter device that is indicated for the treatment of full face wrinkles with red light | Red light: Treatment of full- face wrinkles.
Blue light (only suitable model M226 and MN1 LED Facial Mask): Treatment of mild to moderate inflammatory | Same |

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Shenzhen Dachi communication Co., Ltd.
510(k)s –510(k) Summary

| Comparison Elements | Subject Device | Predicate device 1 | Predicate device 2 | Reference device1 | Reference device 2 | Remark |
| --- | --- | --- | --- | --- | --- | --- |
| K number | K252642 | K241718 | K223919 | K232795 | K242385 | / |
| | wrinkles.
• Blue light is intended for the treatment of mild to moderate inflammatory acne.

EEI101:
The light treatment of Microcurrent Facial Device is indicated for:
• Red light is intended for the treatment of facial wrinkles.
• Blue light is intended for the treatment of mild to moderate inflammatory acne.
• Mixed light (Red and Blue) is intended for the treatment of mild to moderate inflammatory acne. | | of light-based treatment to reduce wrinkles on the face. | and infrared light and treat mild to moderate acne vulgaris of the face. | acne.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Mixed light: Treatment of full face wrinkles. | |
| OTR or prescription | OTC | OTC | OTC | OTC | OTC | Same |

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Shenzhen Dachi communication Co., Ltd.
510(k)s -510(k) Summary

| Comparison Elements | Subject Device | Predicate device 1 | Predicate device 2 | Reference device1 | Reference device 2 | Remark |
| --- | --- | --- | --- | --- | --- | --- |
| K number | K252642 | K241718 | K223919 | K232795 | K242385 | / |
| Treatment site | Face | Face | Face | Face | Face and Neck | Same |
| Power Supply | Input:5V 1A;Output:3.7VCEC101:3.7V/2600mAhEEI101: 3.7V/2600mAh | Adapter input: 5V 0.5AInternal battery:3.7V/600mAh | Control unit :Input voltage 100 -240V AC / 50 - 60 Hz, 15VDC / 2AApplicator:15 V AC | Not publicly available | Input: DC 5V, 1ABuilt-in rechargeablelithium battery: DC3.7V 2500mAh | Different
Note 1 |
| Battery | Lithium-ion | Lithium battery | Li-Ion battery | Not publicly available | Lithium battery | Same |
| Light Therapy Function | | | | | | |
| Light source | Light Emitting Diodes(LED) | Light Emitting Diodes(LED) | Light Emitting Diodes(LED) | LED | Light Emitting Diodes(LED) | Same |
| Wavelength | Blue light: 415±10 nmRed light: 622±10 nm | 415±10nm blue light605±10nm amber light630±10nm red light | B.Light Clear Evo:Red: 645nm±20nmBlue:465nm±20nmB.Light Restore Evo:IR: 860nm±20nmRed: 645nm±20nm | 415nm, 655nm, 845nm | Red: 630nm±5nmBlue: 470 nm±5nmNear-Infrared:850nm±5nmMixed light: 630nm and 850nm | Same |
| Power irradiance | CEC101:Blue light: 0.75mW/cm²Red light: 0.77mW/cm²EEI101:Blue light: 1.12mW/cm²Red light: 1.43mW/cm²Mixed light:1.81mW/cm² | Red light: 2.5mW/cm²Amber light: 15mW/cm²Blue light: 1.4mW/cm² | B.Light Clear Evo:Red: 0.76mW/cm²Blue:1.20mW/cm²Total: 2 mW/cm²B.Light Restore Evo:IR: 1.40mW/cm²Red: 0.56mW/cm²Total:2mW/cm² | Red:1mW/cm²+NIR:1mW/cm²Blue :1mW/cm² | Red:0.89~2.55mW/cm²Blue:1.44~4.09mW/cm²Near-Infrared:1.83~3.05mW/cm²Mixed light:0.95~2.64mW/cm² | Similar
Note 2 |

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Shenzhen Dachi communication Co., Ltd.
510(k)s -510(k) Summary

| Comparison Elements | Subject Device | Predicate device 1 | Predicate device 2 | Reference device1 | Reference device 2 | Remark |
| --- | --- | --- | --- | --- | --- | --- |
| K number | K252642 | K241718 | K223919 | K232795 | K242385 | / |
| Main Materials | ABS, Stainless steel | ABS, PC | Not publicly available | Not publicly available | Not publicly available | Different Note 3 |
| Dimension | CEC101:193.68*68*60mm
EEI101:202.6*69.32*62mm | Not publicly available | System:21cm*15cm*4.3cm
Applicator:12cm*12cm*2.5cm | Not publicly available | MN1:LED Facial Mask:300*208.5*5.5mm
LED Neck Mask:338.5*249.7*5.5mm
M226: LED Facial Mask:300*208.5*5.5mm | Different Note 3 |
| Net Weight | CEC101: 266g
EEI101: 230g | Not publicly available | System: 926g
Applicator: 0.12kg | Not publicly available | Not publicly available | Different Note 3 |
| Safety and EMC | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83
IEC 62471
IEC 62133-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83
IEC 62471
IEC 62133-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-11
IEC 60601-2-57 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-57
IEC 62471 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83
IEC 62471
IEC 62133-2 | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-1 | ISO 10993-11
ISO 10993-5
ISO 10993-10 | All body-contacting materials are complied with ISO 10993-5, ISO 10993-10 and ISO 10993-23 | Same |

Comparison in Detail(s):

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Shenzhen Dachi communication Co., Ltd.
510(k)s – 510(k) Summary

**Note 1:**
The power supply for the subject device is different from that of the predicate device, however the lithium battery of the subject device has passed IEC 62133-2 test, so this difference should not raise any safety/effectiveness questions.

**Note 2:**
Though the irradiance of subject device is a little different from the predicate devices and the reference device, the irradiance of the subject device can be basically covered by the predicate devices and reference devices’ range and they all comply with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.

**Note 3:**
Though the dimension and weight are little different from the predicate device and reference device, this difference is insignificant and do not raise any safety or effectiveness problems. And main materials is a little different from the predicate device 1, but the subject device has passed biocompatibility test, so this difference do not raise any safety of effectiveness problem.

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Shenzhen Dachi communication Co., Ltd.
510(k)s – 510(k) Summary

## VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

### 1) Biocompatibility Safety

The materials of the patient-directly contacting components of the subject device is performed the biocompatibility evaluation in accordance with the “Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020'”, as recommended by FDA. The following testing was performed to, and passed, including:

- ISO 10993-5: 2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2021, Biological evaluation of medical devices – Part 10: Tests for skin sensitization
- ISO 10993-23: 2021, Biological evaluation of medical devices – Part 23: Tests for irritation

### 2) Electrical Safety and EMC Safety

Electrical safety and Eye safety testing was performed to, and passed, the following standards:

- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: electromagnetic compatibility
- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 62133-2 Edition 5.0 2021-09, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems.
- 60601-2-83:2022, Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment.

### 3) Software Verification and Validation

Software documentation consistent with *Basic Documentation* of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

## Summary

Based on the above performance as documented in this application, the subject device was found to have a safety and effectiveness profile that is similar to the predicate devices.

## VIII. Conclusions

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Shenzhen Dachi communication Co.,Ltd.
510(k)s –510(k) Summary

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design and performance, it can be concluded that the Microcurrent Facial Device is as safe, as effective and performs as well as the legally marketed predicate devices and reference devices.

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