Facial Toning device (UIC-189); Facial Toning device (UIC-589)

K233667 · Body Trim Industrial Co., Ltd. · NFO · Feb 12, 2024 · Neurology

Device Facts

• Record ID: K233667
• Device Name: Facial Toning device (UIC-189); Facial Toning device (UIC-589)
• Applicant: Body Trim Industrial Co., Ltd.
• Product Code: NFO · Neurology
• Decision Date: Feb 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Facial Toning device is intended to stimulate the face. The device is intended for cosmetic use.

Device Story

Facial Toning device (models UIC-189, UIC-589) provides transcutaneous electrical stimulation for cosmetic facial toning. UIC-189 is battery-powered with 4 output channels; UIC-589 is AC-powered with 10 output channels. Both utilize microprocessor-controlled electrical pulses delivered via electrode probes or self-adhesive pads. Operated by a clinician in a professional setting, the device applies current to facial tissues to achieve aesthetic effects. The provider selects from 4 operation programs to deliver stimulation. The device includes safety features like automatic shut-off and patient override controls. By stimulating facial tissues, the device aims to provide cosmetic benefits to the user.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), battery safety (IEC 62133-2), and biocompatibility (ISO 10993-5, -10, -23).

Technological Characteristics

Microprocessor-controlled transcutaneous electrical nerve stimulator. UIC-189: 3.7V 5200mAh Li-ion battery; UIC-589: 100-240 VAC. Output: 4 or 10 channels, synchronous, current-controlled. Waveform: Biphasic, rectangular. Accessories: Electrode probes, self-adhesive pads (K160081), cables. Biocompatibility: ISO 10993-1 compliant. Safety: Type BF isolation, current transformer isolation.

Indications for Use

Indicated for prescription cosmetic use to stimulate the face in patients.

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

• Ultra Facial Toning System (K181062)
• Beautiful Image Model 900 Facial Toning Device (K130065)

Submission Summary (Full Text)

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February 12, 2024

Body Trim Industrial Co., Ltd % Bell Bai Regulatory Affairs Project Manager Shenzhen Huatongwei International Inspection Co., Ltd. Building 7, Baiwang Idea Factory, No.1051, Songbai Road Yangguang Community, Xili Subdistrict, Nanshan District Shenzhen, Guangdong China

Re: K233667

Trade/Device Name: Facial Toning device (UIC-189); Facial Toning device (UIC-589) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: November 7, 2023 Received: November 15, 2023

Dear Bell Bai:

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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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.

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-regulatoryassistance/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.

# Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation

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and Rehabilitation 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

510(k) Number (if known) K233667

Device Name

Facial Toning device (UIC-189); Facial Toning device (UIC-589)

Indications for Use (Describe)

The Facial Toning device is intended to stimulate the face. The device is intended for cosmetic use.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

[As required by 21 CFR 807.92]

| 1. Submission Information<br>510(k) Number: | K233667 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 7th, 2023 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | BODY TRIM INDUSTRIAL CO., LTD<br>6F., No. 178, Huanhe Rd., Xindian Dist., New Taipei City 231034,<br>Taiwan (R.O.C.)<br>Tel: [phone]<br>E-mail: [e-mail] |
| Contactor: | Bell Bai<br>Shenzhen Huatongwei International Inspection Co.,Ltd.<br>Building 7, Baiwang Idea Factory, No.1051, Songbai Road, Yangguang<br>Community, Xili Subdistrict, Nanshan District, Shenzhen, Guangdong,<br>China<br>E-mail: [e-mail]<br>Tel: [phone] |
| 2. Device Description | |
| Proprietary Name: | Facial Toning device |
| Model Name: | UIC-189, UIC-589 |
| Classification Name: | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Product Code: | NFO |
| Device Class: | 2 |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | The Facial Toning device is intended to stimulate the face. The device is<br>intended for cosmetic use. |
| Device Description: | The Facial Toning devices, which come in two models (UIC-189,<br>UIC-589), are intended for facial stimulation and are indicated for<br>prescription cosmetic use. The anatomical site for application of the<br>devices are the face. |
| | UIC-189 is battery powered, has 4 output channels and has 4 operation<br>programs. |
| | UIC-589 is AC powered, has 10 output channels and has 4 operation<br>programs. |
| | The device is equipped with accessories of self-adhesive pads (cleared<br>under K160081), electrode probes, electrode cables and adapters. All<br>accessories, including self-adhesive pads, electrode probes, electrode<br>cables and adapters can only be changed or replaced by a qualified person. |

## 3. Predicate Device Identification

| 510(k) Number: | K181062 | K130065 |
|----------------|--------------------------------|------------------------------------------------|
| Product Name: | Ultra Facial Toning System | Beautiful Image Model 900 Facial Toning Device |
| Submitter: | Micro Current Technology, Inc. | Biosonic Technologies, LLC. |

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## 4. Substantially Equivalent Comparison

Table 1-

| Parameters | New Device | Predicate Device 1 | Predicate Device 2 | Remark | |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|---------|
| 510(k) Number: | K233667 | K181062 | K130065 | -- | |
| Marketing clearance date: | -- | July 18, 2018 | April 30, 2014 | -- | |
| Device Name | Facial Toning device | Ultra Facial Toning System | Beautiful Image Model 900 Facial<br>Toning Device | -- | |
| Model | UIC-189 | / | Model 900 | -- | |
| 510(k) Owner | BODY TRIM INDUSTRIAL CO.,<br>LTD | Micro Current Technology, Inc. | Biosonic Technologies, LLC. | -- | |
| Intended use | The Facial Toning device is intended<br>to stimulate the face. The device is<br>intended for cosmetic use. | The Ultra Facial Toning System is<br>intended to stimulate the face. The<br>device is intended for cosmetic use. | The Beautiful Image Model 900 Facial<br>Toning Device uses microcurrent<br>electrical energy to stimulate facial<br>tissues for aesthetic<br>purposes. | Same | |
| Type of use | Prescription Use | Prescription Use | Prescription Use | Same | |
| Power Source(s) | 3.7V 5200mAh Rechargeable lithium<br>battery | 9V alkaline battery | One 6V battery | Similar | |
| - Method of Line Current Isolation | Type BF | Type BF | N/A | Same | |
| - Patient Leakage Current | -- | -- | -- | Same | |
| - Normal Condition (μA) | < 10μA | < 10μA | N/A | Same | |
| - Single Fault Condition (µA) | < 50μA | < 50μA | N/A | Same | |
| Average DC current through<br>electrodes when device is on but no<br>pulses are being applied (µA) | < 0.01 μA | < 0.01μA | None | Same | |
| Number of Output Modes | 4 | 2 | 1 | Similar | |
| Number of Output channels: | 4 | 2 | 1 | Same | |
| - Synchronous or Alternating? | Synchronous | Unpublished | N/A | Similar | |
| - Method of Channel Isolation | Current transformr Isolation | Unpublished | N/A | Same | |
| Regulated Current or Regulated<br>Voltage? | Current control | Unpublished | Both | Same | |
| Software/Firmware/Microprocessor<br>Control? | Yes | Yes | Yes | Same | |
| Automatic Overload Trip? | No | No | Yes | Same | |
| Automatic No-Load Trip? | No | No | Yes | Same | |
| | | | | | |
| Automatic Shut Off? | | Yes | Yes | Yes | Same |
| Patient Override Control? | | Yes | Yes | Yes | Same |
| Indicator | On/Off Status? | Yes | Yes | Yes | Same |
| Display: | Low Battery? | Yes | Yes | Yes | Same |
| | Voltage/Current<br>Level? | Yes | Yes | Yes | Same |
| Timer Range (minutes) | | 1~ 60 minutes, 1min/step | 12 or 15 minutes | None | Same |
| Compliance<br>with<br>Standards? | Voluntary | AAMI/ANSI ES 60601-1, IEC 60601-<br>1-2, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC<br>60601-2-10 | IEC 60601-1 | Same |
| Compliance with 21 CFR 898? | | Yes | Yes | Yes | Same |
| Weight (grams) | | Approx. 700g | Unpublished | 10lbs | Similar |
| Dimensions [W x H x D] | | 220 mm*202mm*143mm | Unpublished | 5.5*15.3*11.3(in.) | |
| Housing Materials & Construction | | ABS | Unpublished | Thermoplastic | Same |
| Waveform | | Pulsed, monophasic | Pulsed, monophasic | biphasic | Same |
| Shape | | Rectangular, trapezoidal, with<br>interphase interval | Rectangular | Rectangular | Same |
| Maximum Output Voltage (volts) | | $160mV\pm10\% @500\Omega$ | $30.8V @500\Omega$ | $0.347V\pm5\% @500\Omega$ | Similar |
| Maximum Output Current (specify<br>units) | | $0.32mA\pm10\% @500\Omega$ | $61.6mA @500\Omega$ | $0.647mA\pm5\% @500\Omega$ | |
| Pulse width (usec) | | $2.5-2500mS\pm10\%$ | 1-10000mS | 3.24-1610mS | |
| Max. pulse frequency (Hz) [or Rate<br>(pps)] | | $0.3-200Hz\pm10\%$ | 0.1-300Hz | 0.621-308.6Hz | |
| Net Charge (μC per pulse) | | $150\muC @500\Omega$ | Unpublished | $0\muC @500\Omega$ | Similar |
| Maximum Phase Charge | | $200\muC@500\Omega$ | Unpublished | $190\muC @,500\Omega$ | |
| Maximum Average Current | | $0.16mA@500\Omega$ | Unpublished | $0.493mA@500\Omega$ | |
| Maximum Current Density | | $0.08mA/cm^2 @500\Omega$ | Unpublished | $1.486mA/cm^2 @500\Omega$ | |
| Maximum Average Power Density | | $12.7\muW/cm^2@500\Omega$ | Unpublished | $366E-6W/cm^2@500\Omega$ | |
| Accessories | | Electrode probes, Self-adhesive pads<br>(K160081), Electrode cables | Electrode probes, DIN plug, Cotton buds | Electrode probes, Electrode cables | Same |
| Biocompatibility | | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Same |

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Table 2-

| Parameters | New Device | Predicate Device 1 | Predicate Device 2 | Remark | |
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|---------|
| 510(k) Number | K233667 | K181062 | K130065 | -- | |
| Device Name | Facial Toning device | Ultra Facial Toning System | Beautiful Image Model 900 Facial Toning | -- | |
| | | | Device | | |
| Model | UIC-589 | / | Model 900 | -- | |
| 510(k) Owner | BODY TRIM INDUSTRIAL CO., LTD | Micro Current Technology, Inc. | Biosonic Technologies, LLC. | -- | |
| Intended use | The Facial Toning device is intended to<br>stimulate the face. The device is intended<br>for cosmetic use. | The Ultra Facial Toning System is<br>intended to stimulate the face. The device<br>is intended for cosmetic use. | The Beautiful Image Model 900 Facial<br>Toning Device uses microcurrent<br>electrical energy to stimulate facial tissues<br>for aesthetic<br>purposes. | Same | |
| Type of use | Prescription Use | Prescription Use | Prescription Use | Same | |
| Power Source(s) | 100-240 VAC, 50-60 Hz | 9V alkaline battery | One 6V battery | Similar | |
| - Method of Line Current<br>Isolation | Type BF | Type BF | N/A | Same | |
| - Patient Leakage Current | | -- | -- | Same | |
| - Normal Condition (μΑ) | < 10μΑ | < 10μA | N/A | | |
| - Single Fault Condition<br>(μΑ) | < 50μA | < 50μA | N/A | | |
| Average DC current through<br>electrodes when device is on<br>but no pulses are being applied<br>(μΑ) | < 0.01μΑ | < 0.01μA | None | Same | |
| Number of Output Modes | 4 | 2 | 1 | Similar | |
| Number of Output channels: | 10 | 2 | 1 | Same | |
| - Synchronous or<br>Alternating? | Synchronous | Unpublished | N/A | Similar | |
| - Method of Channel<br>Isolation | Current transformer Isolation | Unpublished | N/A | Same | |
| Regulated Current or Regulated<br>Voltage? | Current control | Unpublished | Both | Same | |
| Software/Firmware/Microproce<br>ssor Control? | Yes | Yes | Yes | Same | |
| Automatic Overload Trip? | No | No | Yes | Same | |
| Automatic No-Load Trip? | No | No | Yes | Same | |
| Automatic Shut Off? | Yes | Yes | Yes | Same | |
| User Override Control? | Yes | Yes | Yes | Same | |
| Indicator | Yes | Yes | Yes | Same | |
| Display | Status | | | | |
| | Low Battery | Yes | Yes | Yes | Same |
| | Voltage/Current Level | Yes | Yes | Yes | Same |
| Timer Range (minutes) | | 1~ 60 minutes, 1min/step | 12 or 15 minutes | None | Same |
| Compliance with Voluntary Standards? | | AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | IEC 60601-1 | Same |
| Compliance with 21 CFR 898? | | Yes | Yes | Yes | Same |
| Weight (grams) | | 2kg | Unpublished | 10lbs | Similar |
| Dimensions (mm) [W x H x D] | | 360*255*50mm | Unpublished | 5.5*15.3*11.3(in.) | Similar |
| Housing Materials & Construction | | Panel :PMMA<br>Middle Frame :ABS<br>Bottom Case: Iron | Unpublished | Thermoplastic | Similar |
| Waveform | | Pulsed, monophasic | Pulsed, monophasic | biphasic | Same |
| Shape | | Rectangular, trapezoidal, with interphase interval | Rectangular | Rectangular | Same |
| Maximum Output Voltage (volts) | | $160mV\pm10\% @500\Omega$ | $30.8V @500\Omega$ | $0.347V\pm5\% @500\Omega$ | Similar |
| Maximum Output Current (specify units) | | $0.32mA\pm10\% @500\Omega$ | $61.6mA @500\Omega$ | $0.647mA\pm5\% @500\Omega$ | |
| Pulse width (usec) | | 2.5-2500mS±10% | 1-10000mS | 3.24-1610mS | |
| Max. pulse frequency (Hz) [or Rate (pps)] | | 0.3-200Hz±10% | 0.1-300Hz | 0.621-308.6Hz | |
| Net Charge (µC per pulse) | | $150\mu C @500\Omega$ | Unpublished | $0\mu C @500\Omega$ | Similar |
| Maximum Phase Charge, (µC) | | $200\mu C@500\Omega$ | Unpublished | $190\mu C @500\Omega$ | Similar |
| Maximum Average Current, (mA) | | $0.16mA@500\Omega$ | Unpublished | $0.493mA@500\Omega$ | Similar |
| Maximum Current Density, (mA/cm², r.m.s.) | | $0.08mA/cm^2 @500\Omega$ | Unpublished | $0.1.486mA/cm^2 @500\Omega$ | |
| Maximum Average Power Density | | $12.7\mu W/cm^2@500\Omega$ | Unpublished | $366E-6W/cm^2@500\Omega$ | |
| Accessories | | Electrode probes, Self-adhesive pads (K160081), Electrode cables | Electrode probes, DIN plug, Cotton buds | Electrode probes, Electrode cables | Same |
| Biocompatibility | | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Same |

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The proposed device has similar indication for use as well as comparable technical and biocompatibility properties and characterisin, and the minor differences don't raise any additional questions on effectiveness. Therefore, the proposed device is substantially equivalent o the predicate device.

### 5. Non-clinical Testing Summary

Bench tests were conducted to verify that the proposed device met all requirements. The test results with the following stadards. - AAM / ANSES60601-1:2005 & A1:2012, C1:2009(R)2012 & A2:20 0(R)2012 (Cons. Text) [Incl. AMD2:2021], Medial electrical equipment - Part 1: Geneal requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]

-IEC 60601-1-2 Edition 4.1 2021-09 CONSOLIDATED VERSION, Medical electrical equirements for basic sately and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests

- IEC 60601-2-10 Edition 2.1 2016-04. Medical Equipments - Part 2-10. Paricular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators.

- ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytocompatibility)

- ISO 10993-10 Fourth edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for skin sensitization,

- ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation.

- IEC 62133-2 Edition1.0 2017-02, Secondary collaims alkaline or other non-acid electrolytes - Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

#### 6. Conclusion

The conclusion the nondinical tests denonstates that the subject device in 510(k) submission is as affective, as the legally maked predicate device K181062, K130065.