(95 days)
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on standard technologies like microcurrent and LED light.
No
The device is described as an "over-the-counter cosmetic use" device designed for "facial stimulation" and "treatment of facial wrinkles" through microcurrent and light therapy, rather than for diagnosing, treating, or preventing disease.
No
The device is intended for facial stimulation and the treatment of facial wrinkles, and its description focuses on cosmetic use and "better facial wellness," not on diagnosing diseases or conditions.
No
The device description explicitly states it is an "at-home handled device" and includes hardware components like microcurrent, red and infra-red light LEDs, indicator lights, and beeps.
Based on the provided information, the JMOON NouvelleSkin facial toning device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "facial stimulation" and "treatment of facial wrinkles." These are cosmetic and aesthetic purposes, applied directly to the body (in vivo), not for testing samples taken from the body (in vitro).
- Device Description: The description details a device that applies microcurrent and light therapy to the face. This is a physical treatment applied externally.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The JMOON NouvelleSkin device does not fit this description.
N/A
Intended Use / 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.
Product codes
NFO, OHS
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 and infra-red therapy is a treatment that uses red light to reportedly improve your skin's appearance, like reducing wrinkles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Entire Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. No clinical test data was used to support the decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
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.
1
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
2
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).
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
3
Indications for Use
Submission Number (if known)
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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4
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: +86 15626596120 E-mail: blue@ulike.com
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
5
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
6
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 | |
| IEC TR 60601-4-2 | Conforms | |
| EMC | IEC 60601-1-2 | Conforms |
| Home healthcare | ||
| environment | IEC 60601-1-6 | |
| IEC 60601-2-83 | ||
| IEC 60601-1-11 | Conforms | |
| Safety of Device | IEC 62471 | |
| IEC 60601-2-10 | ||
| IEC 60601-2-57 | Conforms | |
| Biocompatibility | ISO 10993-1 | |
| ISO 10993-5 | ||
| ISO 10993-10 | ||
| ISO 10993-23 | Conforms |
8. Substantial Equivalence information
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark
S/D |
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Sponsor | Shenzhen Ulike Smart
Electronics Co., Ltd. | Heat In A Click | Y & J Bio Co., Ltd | N/A |
| Device Name | JMOON NouvelleSkin
facial toning device | 2 Face / Face Evolution | easy Claire | N/A |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark
S/D |
| 510 (K) Number | Pending | K171821 | K213285 | N/A |
| Regulation
number | 21 CFR 882.5890
21 CFR 878.4810 | 21 CFR 882.5890 | 21 CFR 878.4810 | N/A |
| Classification
Panel | Neurology,
General & Plastic Surgery | Neurology,
General & Plastic
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
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 | 2 Face / Face Evolution
is a hand-held device for
over-the counter
aesthetic purposes.
(1) The EMS mode is
indicated for facial
stimulation;
(2) The Photon mode:
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. | The easy Claire is an
over-the-counter medical
device intended for the use
in the treatment of full face
wrinkles | Difference
Note 1 |
| Anatomical Sites | Entire Face | Entire Face | Entire Face | Same |
| Intended
Environment | Home use | Home use | Home use | Same |
| Type of use | OTC | OTC | OTC | Same |
| Design | Hand-held device | Hand-held device | Mask | Difference
Note 2 |
| Main Unit
Weight | 210g | 200g | Unknown | Difference
Note 2 |
| Dimensions of
device (inch) | 94.4mm99.6mm47.8mm | 158mm56mm51.5mm | Unknown | Difference
Note 2 |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark
S/D |
| [W x L x D] | | | | |
| Power source | DC 7.7V 1500mAh | DC 3.7V 2200mAh | Rechargeable lithium-ion
battery
Adapter:
Input: AC 100-240V,
50/60Hz,
Output: DC 5V, 2A. | Difference
Note 3 |
| For Microcurrent facial stimulation function | | | | |
| Average DC
current through
electrodes when
device is on but no
pulses are being
applied | 0A | 0A | N/A | Same |
| Number of Output
channels | 3 | 2 | N/A | Difference
Note 4 |
| Regulated Current
or Regulated
Voltage? | Both | Both | N/A | Same |
| Software/Firmware
/Microprocessor
Control? | Yes | Yes | Unknown | Same |
| Automatic
Overload Trip? | Yes | No | Unknown | Difference
Note 4 |
| Automatic Shut
Off | Yes | Yes | Unknown | Same |
| Microcurrent Specification | | | | |
| Waveform and
Shape | Pulsed Biphasic,
Rectangular | Pulsed Biphasic,
Modulated Square | N/A | Difference
Note 5 |
| Maximum Output
Voltage (specify
units) | 1.90V ±20% @ 500Ω
2.06V ±20% @ 1kΩ
2.09V ±20% @ 2kΩ
2.16V ±20% @ 10kΩ | 310mV @ 500Ω
1.16V @ 2kΩ
5.56V @ 10kΩ | N/A | Difference
Note 5 |
| Maximum Output
Current (specify | 3.8mA ±20% @ 500Ω
2.06mA ±20% @ 1kΩ | 620μA @ 500Ω
580μΑ @ 2kΩ | N/A | Difference
Note 5 |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark
S/D |
| units) | 1.045mA±20% @ 2Ω
0.216mA±20% @ 10Ω | 556μΑ @ 10Ω | | |
| Output Tolerance | +/-20% | +/-10% | N/A | Difference
Note 5 |
| Pulse Width
(specify units) | LIFT:52us
SL: 31/56us
EYE:45/56/71/76/82us | 60ms | N/A | Difference
Note 5 |
| Frequency (Hz) | LIFT: 12.5 Hz
SL: 125.0 Hz
EYE:50.0Hz | 8.333Hz | N/A | Difference
Note 5 |
| Maximum Phase
Charge (lie) | 5.25μC@ 500Ω | 26.31μC @ 500Ω | N/A | Difference
Note 5 |
| Maximum Current
Density (mA/ cm²) | 8.84mA/cm²@ 500Ω
4.87 mA/cm²@ 1kΩ
2.47 mA/cm² @ 2Ω
0.48 mA/cm² @ 10Ω
(The Minimum Electrode
Size: 0.31cm²) | 0.330mA/ cm² @500Ω
(The Minimum Electrode
Size: 2.91cm²) | N/A | Difference
Note 5 |
| Maximum Power
Density (mW/
cm²) | 12.11mW/cm²@ 500Ω
7.36 mW/cm²@ 1kΩ
3.78 mW/cm² @ 2Ω
0.78 mW/cm² @ 10Ω
(The Minimum Electrode
Size: 0.31cm²) | 4.34μW/ cm² @500Ω
(The Minimum Electrode
Size: 2.91cm²) | N/A | Difference
Note 5 |
| Net Charge ( per
pulse) | 10.50μC @500Ω | Unknown | N/A | Difference
Note 6 |
| Time Range
(minutes) | EMS Mode (10 minutes) | EMS Mode (5 minutes) | N/A | Difference
Note 5 |
| | For LED treatment function | | | |
| Wavelength | RED (630nm ± 10nm) | Red (630nm±3nm) | RED (630nm) | Difference
Note 7 |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark
S/D |
| | IR (855nm±10nm) | Blue (415nm±3nm) | IR (850nm) | |
| Irradiance | Stamp Mode: | | | |
| | Level 1: 18±20% mW/cm² | Red light: 73.26
mW/cm²±10%
Blue light: 64.10
mW/cm²±10% | 20±20% mW/ cm² total | Difference
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
(minutes) | 6 minutes | 5~7 minutes | 9 minutes | Difference
Note 7 |
| Additional Features | | | | |
| Type BF applied
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
IEC 60601-1-6
IEC 60601-2-10
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
compliance | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Difference
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 | | | |
7
Shenzhen Ulike Smart Electronics Co., Ltd. Sponsor: JMOON NouvelleSkin Facial Toning Device Subject Device:
8
Shenzhen Ulike Smart Electronics Co., Ltd. Sponsor: JMOON NouvelleSkin Facial Toning Device Subject Device:
9
Shenzhen Ulike Smart Electronics Co., Ltd. Sponsor: JMOON NouvelleSkin Facial Toning Device Subject Device:
10
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:
11
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 (K171821). In particular, the maximum power density meets the maximum allowed value 0.25 (W/cm² ) required in FDA guidance and the timer range of the subject device is close to primary predicate device (K171821). The timer range is based on the intended use, and user can adjust the time and frequency by using the modes described in user manual.
Regarding the maximum output voltage, at 500 Ω and 2k Ω (the most common impedance values), although the output voltage of the tested equipment is higher than that of the equivalent equipment, the maximum output voltage of the tested equipment
12
1.90V@500 Ω and 2.09V@2k Ω is much lower than the output voltage of 10V specified in clause 201.7.2.101 of IEC 60601-2-10, which is a safe voltage that the human body can withstand.According to FDA approved similar medical device products, such as K220198 approval certificate with a maximum output voltage of 39.3 Vpp @ 500 Ω (+/-20%), K230506 approval certificate with a maximum output voltage of 20Vpp (@ 500Ω), 32Vpp (@ 2k Ω ), and 44Vpp (@ 10k Ω ), and K221443 approval certificate with a maximum output voltage of 20Vpp (@ 500 Ω), 32Vpp (@ 2k Ω), and 44Vpp ( @ 10k 2 ), the output voltage of the tested equipment is much lower than the indicators of similar devices mentioned above.
Regarding the output tolerance, the output tolerance of ± 20% set by the tested equipment complies with the provisions of clause 201.12.1.102 in IEC 60601-2-10, which states that "an accuracy of ± 20% is safe enough for therapeutic applications because pulse parameters are set based on subjective patient reactions", and is the same as the product output tolerance specified as +/-20% in the K220198 approval certificate.
Regarding the The current density, The current density of the tested device (e.g. 8.84 mA/cm² ) is similar to that of FDA approved similar medical device products, such as the maximum output current of 8.8mA/cm² @ 500 Ω in K221443 approval certificate and 8.8mA/cm2 @ 500 Ω in K230506 approval certificate/ cm2@500 Ω , In response to exceeding the limit of 2 mA/cm2 specified in IEC 60601-2-10, we provide relevant risk analysis content in accordance with clauses 201.4.2 and 201.7.9.2.101g) of IEC 60601-2-10. This is achieved by labeling the equipment and using indicator lights in the corresponding gear positions to ensure compliance with standards and the safety of the equipment and its accessories.
Ulike has provided adequate electrical safety and performance testing, which were conducted according to applicable standards for nerve and muscle stimulators (including IEC 60601-1 and IEC 60601-2-10) as well as lab bench performance evaluation. Therefore, these differences will not any raise safety or effectiveness issues.
Note 6:
The maximum net charge per test is 10.50 ↓C, which is much lower than the requirement in clause 8.4.3 of IEC 60601-1 that the stored charge should not exceed 45 µ C, and similar medical device products approved by the FDA, such as K232001 approval certificate with a net charge of 38.4 ↓C and K233667 approval certificate with a net charge of 150 µ C @ 500Ω. Therefore, the difference in net charge will not affect the safety or effectiveness of the tested device.
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Note 7:
The LED "Wavelengths", and "Irradiance" are different from the predicate device (K171821). The subject device use red light (630nm) and IR light (855nm), while the predicate devices (K171821) use red light (630mm) and blue light (415nm). The wavelength of red light of the subject device(630nm) is the same as the predicate device K171821 (630nm), but the Irradiance of the predicate devices (K171821) is greater than the subject device. Therefore, we choose the predicate devices (K213285) as the comparison of LED treatment mode, and the subject device is closer to the predicate devices (K213285).
Although the LED "Wavelengths", and "Irradiance" are a slightly different from the predicate devices (K213285), the wavelength of red light of the subject device(630nm) is the same as the predicate device K213285 (630nm), and the IR light of the subject device (855nm±10nm) is very close to the predicate device K213285 (850nm). The Irradiance of the subject device (including level 1: 18 mW/cm2 ; Level 2: 20 mW/cm2 ; Level 3:23 mW/cm²; Level 4: 26 mW/cm² , Level 5: 29 mW/cm² ) is very close to predicate device K213285 (20±20% mW/ cm² total).
They all comply with the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62471 safety standards' requirements. Additional HFE report and bench evaluation are performed to ensure its safety and effectiveness. Therefore, these slight differences will not raise any safety or effectiveness issues.
Note 8:
The testing standard of irritation is different. The subject device testing according to ISO10993-23, and while the predicate device is tested according to ISO10993-10 for updating the standard ISO 10993-23, replacing the irritation reaction test in ISO 10993-10.
The differences only pertain to the irritation testing of biocompatibility and do not affect any other performance of safety and/or effectiveness. Ulike has provided the irritation testing report in this submission, which demonstrates the device compliance with ISO 10993-23 for irritation reaction testing. Therefore, the difference will not raise any safety or effectiveness issues.
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Comparison to predicate device
The technological characteristics, features, specifications, materials, and intended use of Micro-current function and LED function are substantially equivalent to the predicate devices (K171821 and K213285) quoted above. Even though there is a minor difference in output parameters and construction between the subject device and predicate devices, and the differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
Finial Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR part 807 and based on the relative information provided in this premarket notification, we conclude that the JMOON NouvelleSkin Facial Toning Device is substantially equivalent to 2 Face / Face Evolution (K171821) and easy Claire (K213285) with regard to safety and effectiveness.