JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)

K243393 · Shenzhen Ulike Smart Electronics Co., Ltd. · NFO · Feb 3, 2025 · Neurology

Device Facts

• Record ID: K243393
• Device Name: JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)
• Applicant: Shenzhen Ulike Smart Electronics Co., Ltd.
• Product Code: NFO · Neurology
• Decision Date: Feb 3, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

JMOON NouvelleSkin facial toning device is intended for facial stimulation and indicated for over-the-counter cosmetic use. JMOON NouvelleSkin facial toning device is an over-the-counter device that emits energy in the red and near-infrared spectrum, designed for the treatment of facial wrinkles.

Device Story

JMOON NouvelleSkin is a handheld, at-home facial toning device. It utilizes microcurrent electrical stimulation and red/near-infrared LED light therapy. The device features three output channels for microcurrent impulses to provide facial stimulation and LED emitters (630nm red, 855nm IR) for wrinkle reduction. Users operate the device manually, guided by indicator lights and audible beeps. The device includes an automatic overload trip and automatic shut-off for safety. It is intended for cosmetic use to improve facial appearance. The healthcare provider does not operate the device; it is for patient self-use. The device is battery-powered (DC 7.7V).

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Evidence is based on bench testing, including electrical safety, EMC, home healthcare environment, device safety, and biocompatibility.

Technological Characteristics

Handheld device; microcurrent stimulation (pulsed biphasic, rectangular) and LED therapy (630nm red, 855nm IR). Power: 7.7V 1500mAh battery. Biocompatibility per ISO 10993-1, -5, -10, -23. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-2-57, IEC 62471. Type BF applied part.

Indications for Use

Indicated for over-the-counter cosmetic facial stimulation and treatment of facial wrinkles in adults.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• 2 Face / Face Evolution (K171821)
• easy Claire (K213285)

Reference Devices

• K220198
• K230506
• K221443
• K232001
• K233667

Submission Summary (Full Text)

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February 3, 2025

Shenzhen Ulike Smart Electronics Co., Ltd. Blue Yang Official Correspondent 810, Building 1, Xunmei Science and Technology Plaza, No. 8 Keyuan Road, Science Park Community, Yuehai Sub-District, Na ShenZhen, 518000 China

# Re: K243393

Trade/Device Name: JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) Regulation Numbers: 21 CFR 882.5890; 21 CFR 878.4810 Regulation Names: Transcutaneous Electrical Nerve Stimulator For Pain Relief; Laser Surgical Instrument For Use in General and Plastic Surgery And In Dermatology. Regulatory Class: Class II Product Codes: NFO, OHS Dated: December 27, 2024 Received: December 27, 2024

Dear Blue Yang:

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.

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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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatory

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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,

# Tushar Bansal -S

for Heather Dean, PhD 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

Enclosure

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# Indications for Use

Submission Number (if known)

K243393

Device Name

JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U MP)

Indications for Use (Describe)

JMOON NouvelleSkin facial toning device is intended for facial stimulation and indicated for overthe-counter cosmetic use.

JMOON NouvelleSkin facial toning device is an over-the-counter device that emits energy in the red and near-infrared spectrum, designed for the treatment of facial wrinkles.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510k Summary

This 510(k) Summary is being submitted in accordance with requirements of T itle 21, CFR Section 807.92.

The assigned 510(k) Number: K243393 Date of Preparation: 31/01/2025

# 1. Information of Submitter and correspondent

# Submitter's information

Submitter Name: Shenzhen Ulike Smart Electronics Co., Ltd. Submitter Address: 810, Building 1, Xunmei Science and Technology Plaza, No. 8 Keyuan Road, Science Park Community, Yuehai Sub-District, Nanshan District, Shenzhen 518000, Guangdong, P.R. China Establishment Registration Number: 3023339103 Contact Person (including Title): Blue Yang Tel: [phone] E-mail: [e-mail]

# 2. Device Identification

- Type of 510(k) submission: Traditional
- Common Name: stimulator, transcutaneous electrical, aesthetic purposes;
- light based over the counter wrinkle reduction
- Trade Name: JMOON NouvelleSkin facial toning device
- Regulation Names: Transcutaneous Electrical Nerve Stimulator For Pain Relief; Laser Surgical Instrument For Use in General and Plastic Surgery And In Dermatology.
- Regulation Medical Specialty: Neurology; General & Plastic Surgery
- Review Panel: Neurology; General & Plastic Surgery
- Product Code: NFO, OHS
- Regulation Numbers: 21 CFR 882.5890; 21 CFR 878.4810
- Regulatory Class: Class II

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# 3. Discussion of Non-clinical test and clinical test for Determination of Substantial Equivalence are as follows:

### 3.1 Non-clinical testing

A series of safety and performance tests were conducted on the subject device.

- Performance Test
- Biocompatibility test
- Electrical safety
- Home healthcare environment

All the test results demonstrate JMOON NouvelleSkin Facial Toning Device meets the requirements of its predefined acceptance criteria and intended use, and it is substantially equivalent to the predicate device.

### 3.2 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

| Sponsor | Heat In A Click | Y & J Bio Co., Ltd |
|-------------------|-------------------------|--------------------|
| Device Name | 2 Face / Face Evolution | easy Claire |
| 510(k) Number | K171821 | K213285 |
| Product Code | NFO, OHS, OLP | OHS |
| Regulation Number | 21 CFR 882.5890 | 21 CFR 878.4810 |
| Regulation Class | Class II | Class II |

### 4. Predicate Device Information

### 5. Device Description

Jmoon NouvelleSkin Facial Toning device is an at-home handled device that provides an advanced, easy-to-use and efficient solution for better facial wellness. This device includes microcurrent, red and infra-red light LED, which allow you to customize your treatments according to your face skin. The device provides indicator lights and beeps feedback to guide the user during the treatment cycle.

The microcurrent therapy will deliver 3 different low-level electrical microcurrent impulses on face within a few minutes to complete facial stimulation. The red light

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and infra-red therapy is a treatment that uses red light to reportedly improve your skin's appearance, like reducing wrinkles.

# 6. Indications for Use

JMOON NouvelleSkin facial toning device is intended for facial stimulation and indicated for over-the-counter cosmetic use.

JMOON NouvelleSkin facial toning device is an over-the-counter device that emits energy in the red and near-infrared spectrum, designed for the treatment of facial wrinkles.

# 7. Test Summary

JMOON NouvelleSkin facial toning device has been evaluated for safety and performance by lab bench testing as follows:

| Test Type | Standard | Outcome |
|--------------------------------|------------------------------------------------------------|----------|
| Electrical safety | IEC 60601-1<br>IEC TR 60601-4-2 | Conforms |
| EMC | IEC 60601-1-2 | Conforms |
| Home healthcare<br>environment | IEC 60601-1-6<br>IEC 60601-2-83<br>IEC 60601-1-11 | Conforms |
| Safety of Device | IEC 62471<br>IEC 60601-2-10<br>IEC 60601-2-57 | Conforms |
| Biocompatibility | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23 | Conforms |

### 8. Substantial Equivalence information

| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark<br>S/D |
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Sponsor | Shenzhen Ulike Smart<br>Electronics Co., Ltd. | Heat In A Click | Y & J Bio Co., Ltd | N/A |
| Device Name | JMOON NouvelleSkin<br>facial toning device | 2 Face / Face Evolution | easy Claire | N/A |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark<br>S/D |
| 510 (K) Number | Pending | K171821 | K213285 | N/A |
| Regulation<br>number | 21 CFR 882.5890<br>21 CFR 878.4810 | 21 CFR 882.5890 | 21 CFR 878.4810 | N/A |
| Classification<br>Panel | Neurology,<br>General & Plastic Surgery | Neurology,<br>General & Plastic<br>Surgery | General & Plastic Surgery | N/A |
| Classification | Class II | Class II | Class II | N/A |
| Product code | NFO, OHS | NFO, OHS, OLP | OHS | N/A |
| Indication for Use | JMOON NouvelleSkin<br>facial toning device is<br>intended for facial<br>stimulation and indicated<br>for over-the-counter<br>cosmetic use.<br>JMOON NouvelleSkin<br>facial toning device is an<br>over-the-counter device that<br>emits energy in the red and<br>near-infrared spectrum,<br>designed for the treatment<br>of facial wrinkles | 2 Face / Face Evolution<br>is a hand-held device for<br>over-the counter<br>aesthetic purposes.<br>(1) The EMS mode is<br>indicated for facial<br>stimulation;<br>(2) The Photon mode:<br>The red light is intended<br>for the treatment of<br>periorbital wrinkles and<br>the blue light is intended<br>for the treatment of the<br>mild to moderate<br>inflammatory acne. | The easy Claire is an<br>over-the-counter medical<br>device intended for the use<br>in the treatment of full face<br>wrinkles | Difference<br>Note 1 |
| Anatomical Sites | Entire Face | Entire Face | Entire Face | Same |
| Intended<br>Environment | Home use | Home use | Home use | Same |
| Type of use | OTC | OTC | OTC | Same |
| Design | Hand-held device | Hand-held device | Mask | Difference<br>Note 2 |
| Main Unit<br>Weight | 210g | 200g | Unknown | Difference<br>Note 2 |
| Dimensions of<br>device (inch) | 94.4mm*99.6mm*47.8mm | 158mm*56mm*51.5mm | Unknown | Difference<br>Note 2 |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark<br>S/D |
| [W x L x D] | | | | |
| Power source | DC 7.7V 1500mAh | DC 3.7V 2200mAh | Rechargeable lithium-ion<br>battery<br>Adapter:<br>Input: AC 100-240V,<br>50/60Hz,<br>Output: DC 5V, 2A. | Difference<br>Note 3 |
| For Microcurrent facial stimulation function | | | | |
| Average DC<br>current through<br>electrodes when<br>device is on but no<br>pulses are being<br>applied | 0A | 0A | N/A | Same |
| Number of Output<br>channels | 3 | 2 | N/A | Difference<br>Note 4 |
| Regulated Current<br>or Regulated<br>Voltage? | Both | Both | N/A | Same |
| Software/Firmware<br>/Microprocessor<br>Control? | Yes | Yes | Unknown | Same |
| Automatic<br>Overload Trip? | Yes | No | Unknown | Difference<br>Note 4 |
| Automatic Shut<br>Off | Yes | Yes | Unknown | Same |
| Microcurrent Specification | | | | |
| Waveform and<br>Shape | Pulsed Biphasic,<br>Rectangular | Pulsed Biphasic,<br>Modulated Square | N/A | Difference<br>Note 5 |
| Maximum Output<br>Voltage (specify<br>units) | 1.90V ±20% @ 500Ω<br>2.06V ±20% @ 1kΩ<br>2.09V ±20% @ 2kΩ<br>2.16V ±20% @ 10kΩ | 310mV @ 500Ω<br>1.16V @ 2kΩ<br>5.56V @ 10kΩ | N/A | Difference<br>Note 5 |
| Maximum Output<br>Current (specify | 3.8mA ±20% @ 500Ω<br>2.06mA ±20% @ 1kΩ | 620μA @ 500Ω<br>580μΑ @ 2kΩ | N/A | Difference<br>Note 5 |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark<br>S/D |
| units) | 1.045mA±20% @ 2Ω<br>0.216mA±20% @ 10Ω | 556μΑ @ 10Ω | | |
| Output Tolerance | +/-20% | +/-10% | N/A | Difference<br>Note 5 |
| Pulse Width<br>(specify units) | LIFT:52us<br>SL: 31/56us<br>EYE:45/56/71/76/82us | 60ms | N/A | Difference<br>Note 5 |
| Frequency (Hz) | LIFT: 12.5 Hz<br>SL: 125.0 Hz<br>EYE:50.0Hz | 8.333Hz | N/A | Difference<br>Note 5 |
| Maximum Phase<br>Charge (lie) | 5.25μC@ 500Ω | 26.31μC @ 500Ω | N/A | Difference<br>Note 5 |
| Maximum Current<br>Density (mA/ cm²) | 8.84mA/cm²@ 500Ω<br>4.87 mA/cm²@ 1kΩ<br>2.47 mA/cm² @ 2Ω<br>0.48 mA/cm² @ 10Ω<br>(The Minimum Electrode<br>Size: 0.31cm²) | 0.330mA/ cm² @500Ω<br>(The Minimum Electrode<br>Size: 2.91cm²) | N/A | Difference<br>Note 5 |
| Maximum Power<br>Density (mW/<br>cm²) | 12.11mW/cm²@ 500Ω<br>7.36 mW/cm²@ 1kΩ<br>3.78 mW/cm² @ 2Ω<br>0.78 mW/cm² @ 10Ω<br>(The Minimum Electrode<br>Size: 0.31cm²) | 4.34μW/ cm² @500Ω<br>(The Minimum Electrode<br>Size: 2.91cm²) | N/A | Difference<br>Note 5 |
| Net Charge ( per<br>pulse) | 10.50μC @500Ω | Unknown | N/A | Difference<br>Note 6 |
| Time Range<br>(minutes) | EMS Mode (10 minutes) | EMS Mode (5 minutes) | N/A | Difference<br>Note 5 |
| | For LED treatment function | | | |
| Wavelength | RED (630nm ± 10nm) | Red (630nm±3nm) | RED (630nm) | Difference<br>Note 7 |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark<br>S/D |
| | IR (855nm±10nm) | Blue (415nm±3nm) | IR (850nm) | |
| Irradiance | Stamp Mode: | | | |
| | Level 1: 18±20% mW/cm² | Red light: 73.26<br>mW/cm²±10%<br>Blue light: 64.10<br>mW/cm²±10% | 20±20% mW/ cm² total | Difference<br>Note 7 |
| | Level 2: 20 ±20%mW/cm² | | | |
| | Level 3: 23 ±20%mW/cm² | | | |
| | Level 4: 26±20% mW/cm² | | | |
| | Level 5: 29±20% mW/cm² | | | |
| Time Range<br>(minutes) | 6 minutes | 5~7 minutes | 9 minutes | Difference<br>Note 7 |
| Additional Features | | | | |
| Type BF applied<br>part | Type BF applied part | Type BF applied part | Unknown | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Safety | IEC 60601-1 | IEC 60601-1<br>IEC 60601-1-6<br>IEC 60601-2-10<br>IEC 60601-2-57 | IEC 60601-1 | Same |
| | IEC 60601-1-6 | | IEC 60601-1-6 | |
| | IEC 60601-1-11 | | IEC 60601-1-11 | |
| | IEC 62471 | | IEC 62471 | |
| | IEC 60601-2-10 | | IEC 60601-2-57 | |
| | IEC 60601-2-57 | | | |
| Biocompatibility<br>compliance | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Difference<br>Note 8 |
| | ISO 10993-5 | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-10 | ISO 10993-10 | ISO 10993-10 | |
| | ISO 10993-23 | ISO 10993-12 | ISO 10993-12 | |
| | ISO 10993-12 | | | |

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#### Shenzhen Ulike Smart Electronics Co., Ltd. Sponsor: JMOON NouvelleSkin Facial Toning Device Subject Device:

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Shenzhen Ulike Smart Electronics Co., Ltd. Sponsor: JMOON NouvelleSkin Facial Toning Device Subject Device:

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#### Shenzhen Ulike Smart Electronics Co., Ltd. Sponsor: JMOON NouvelleSkin Facial Toning Device Subject Device:

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#### Sponsor: Shenzhen Ulike Smart Electronics Co., Ltd. Subject Device: JMOON NouvelleSkin Facial Toning Device

### Comparison in Detail(s):

### Note 1:

2 Face / Face Evolution (K171821) as the primary predicate device for EMS function and easy Claire (K213285) as the secondary predicate device for LED function. Ulike finds that the combined the predicate devices 2 Face/Face Evolution (K171821), and easy Claire (K213285) can be substantially equivalent to the subject device per the predicates' 510(k) summary and equivalence discussion. So the differences will not raise any safety or effectiveness issues.

### Note 2:

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Although the design, appearance and dimensions are different between the subject and predicate devices, these parameters are only related to the product's shape, dimensions and appearance as well as its operation in a home environment. They are not related to any other aspects of safety and/or effectiveness. Ulike provides the IEC testing reports and the testing report shows that the device is compliant with IEC60601-1-11 and IEC60601-1-6. Therefore, these differences will not raise any safety or effectiveness issues.

### Note 3:

Although the "Power Supply" is slightly different from that of predicate device and the feature is only related to Electric Safety, it is not related to any safety or effectiveness issues. The lithium battery of the subject device has been tested under standard IEC 62133-2 and has been found to comply with safety standards' requirements of the IEC 60601. Therefore, this slight difference should not raise any safety or effectiveness issues.

### Note 4:

Although the number of output channels and Automatic Overload Trip of the subject device are different from the predicate devices, they all comply with the requirements of IEC 60601-1 and IEC 60601-2-10. Therefore, the differences in function specifications will not raise any safety or effectiveness issues.

### Note 5:

Though the electrical microcurrent stimulation characteristics of the 2 Face / Face Evolution (including waveform and shape, maximum output voltage, maximum output current, maximum current density, maximum power density, output tolerance, pulse width, frequency, Maximum Phase Charge and time range) are different from the predicate device (K171821).These differences are intended to provide an improved user experience and do not significantly affect the subject device's safety and effectiveness relative to the predicate device (K17182…