Myolight Microcurrent Handpiece

K243063 · Raja Trading Company, Inc. · NFO · Feb 10, 2025 · Neurology

Device Facts

• Record ID: K243063
• Device Name: Myolight Microcurrent Handpiece
• Applicant: Raja Trading Company, Inc.
• Product Code: NFO · Neurology
• Decision Date: Feb 10, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is indicated for aesthetic use, including facial and neck or body skin stimulation.

Device Story

MyoLight Microcurrent Handpieces are aesthetic electrical stimulation devices used with a main control unit featuring a color touch screen. The system includes two handpieces (small for face, large for body) containing electrodes that deliver microcurrent. The control unit manages power and therapy parameters, providing step-by-step guidance via the touch screen. Used by licensed professionals (aestheticians, dermatologists, etc.) in clinical settings to provide skin stimulation. The device displays therapy type, remaining time, and parameters during operation. The output is intended to facilitate aesthetic treatments; it does not provide diagnostic information. The device benefits patients by providing professional-grade aesthetic skin stimulation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), nerve/muscle stimulator performance (IEC 60601-2-10), biocompatibility (ISO 10993), and software verification/validation.

Technological Characteristics

Microcurrent stimulator; regulated voltage output; pulsed biphasic rectangular waveform modulated by trapezoidal. Materials: Molded PC-ABS housing, Stainless Steel 304 and PMMA contact surfaces. Power: 110-240 VAC, 50-60 Hz. Connectivity: Handpieces connect to a microprocessor-controlled main unit with LCD touch screen. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62366.

Indications for Use

Indicated for aesthetic use, including facial, neck, and body skin stimulation in professional settings (aestheticians, med spas, plastic surgeons, dermatologists). Not for home use.

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

• BTL-785BNF Handpiece (K232172)

Reference Devices

• Rejuvenique Facial Toning System (K011935)
• EZZI-LIFT (K191951)

Submission Summary (Full Text)

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February 10, 2025

Raja Trading Company, Inc. % Yolando Smith Smith Assoicates 1469 Harwell Ave Crofton, Maryland 21114

Re: K243063

Trade/Device Name: Myolight Microcurrent Handpiece Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: January 15, 2025 Received: January 15, 2025

Dear Yolando Smith:

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

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

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

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(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 OS 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 Rue"). 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-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-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).

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Sincerely,

# Heather L. Dean -S

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)

K243063

Device Name

Myolight Microcurrent Handpiece

Indications for Use (Describe)

The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.

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)

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# 510(k) Summary

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

510(k) Number: K243063

## 1. Date of Preparation

2/7/2025

# 2.

| Name: | RAJA Trading Company Inc. |
|-----------------|-------------------------------------------------|
| Address: | 2801 Juniper Street, Suite 2, Fairfax, VA 22031 |
| Contact Person: | Robert J. Adipietro |
| Title: | Vice President |
| Telephone: | 561-868-4600 |
| Fax: | 561-258-0207 |
| Email: | [e-mail] |

## 3. Identification of the Proposed Device

| Trade Name: | MyoLight Microcurrent Handpiece |
|----------------------|----------------------------------------------------------|
| Common Name: | Microcurrent Stimulator |
| Classification Name: | Stimulator, Transcutaneous Electrical, Aesthetic Purpose |
| Classification: | Class II |
| Product Code: | NFO |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |

| Attachment | Regulation Name | Regulation No. | Product<br>code | Class |
|-------------------------------------|--------------------------------------------------------------|----------------|-----------------|-------|
| MyoLight Microcurrent<br>Handpieces | Stimulator, Transcutaneous<br>Electrical, Aesthetic Purposes | 882.5890 | NFO | 2 |

#### Identification of Predicate Devices 4.

| Primary<br>Predicate Device | Manufacturer | Trade Name | Product Code | 510K<br>Number |
|----------------------------------|----------------------|-------------------------------------|--------------|----------------|
| Aesthetic TENS<br>Device | BTL Industries, Inc. | BTL-785BNF Handpiece | NFO | K232172 |
| Reference Predicate<br>Device #1 | Manufacturer | Trade Name | | 510K<br>Number |
| Aesthetic TENS<br>Device | Salton, Inc. | Rejuvenique Facial Toning<br>System | NFO | K011935 |
| Reference Predicate<br>Device #2 | Manufacturer | Trade Name | | 510K<br>Number |
| Aesthetic TENS<br>Device | Avazzia, Inc. | EZZI-LIFT | NFO | K191951 |

#### 5. Product Description

The subject device, the MyoLight Microcurrent Handpieces are intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the device. There are two MyoLight Microcurrent Handpieces that connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body. The handpieces are different in dimensions but not function. The handpieces contain the electrodes that deliver microcurrent for aesthetic use.

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The subject device is intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the handpieces. The on-screen information guides the user step-bystep through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about therapy type, remaining therapy time and main therapy parameters on the screen.

The product is only sold to professionals licensed to administer the treatments including aestheticians, med spas, plastic surgeons and dermatologists and other licensed professionals. It is not intended to be sold to the consumer or for home use.

#### 6. Indications for Use

The device is indicated for aesthetic use, including facial and neck or body skin stimulation.

| Specifications | Subject Device | Primary<br>Predicate Device | Reference<br>Predicate<br>Device # 1 | Reference<br>Predicate<br>Device # 2 |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K243063 | K232172 | K011935 | K191951 |
| Manufacturer | RAJA Trading<br>Company | BTL Industries, Inc | Salton, Inc. | Avazzia, Inc. |
| Device Name | MyoLight<br>Microcurrent<br>Handpiece | BTL-785BNF<br>Handpiece | Rejuvenique<br>Facial Toning<br>System | EZZI-LIFT |
| Classification &<br>Subsequent Product<br>Codes | NFO | NFO | NFO | NFO |
| Regulation Number | 882.5890 | 882.5890 | 882.5890 | 882.5890 |
| Classification Name: | Transcutaneous<br>Electrical Never<br>Stimulator for Pain<br>Relief | Transcutaneous<br>Electrical Never<br>Stimulator for Pain<br>Relief | Transcutaneous<br>Electrical Never<br>Stimulator for<br>Pain Relief | Transcutaneous<br>Electrical Never<br>Stimulator for<br>Pain Relief |
| Common Name | Esthetic TENS Device | Esthetic TENS<br>Device | Esthetic TENS<br>Device | Esthetic TENS<br>Device |
| Indications for use | The device is indicated<br>for aesthetic use<br>including facial and<br>neck or body skin<br>stimulation. | The device is<br>indicated for<br>aesthetic use<br>including facial and<br>neck or body skin<br>stimulation. | Indicates for<br>Cosmetic Use | The Avazzia<br>OTC TENS for<br>aesthetics,<br>model BEST-<br>AVI™ : EZZI-<br>LIFTTM Device<br>is indicated for<br>over-the-<br>counter<br>aesthetic use<br>including facial<br>and neck<br>stimulation or<br>body skin<br>stimulation. |
| Specifications | Subject Device | Primary<br>Predicate Device | Reference<br>Predicate<br>Device # 1 | Reference<br>Predicate<br>Device # 2 |
| Anatomic Sites | Face, Neck, and Body | Face, Neck, and<br>Body | Face | Face, Neck, and<br>Body |
| Principal of Operation | Handpieces with<br>electrodes that deliver<br>electrical stimulation<br>attached to a main<br>body that contains the<br>power supplies, the<br>microprocessor control<br>unit, and the touch-<br>screen user interface. | Handpieces with<br>electrodes that<br>deliver electrical<br>stimulation attached<br>to a main body that<br>contains the power<br>supplies, the<br>microprocessor<br>control unit, and the<br>touch-screen user<br>interface. | Face Mask with<br>electrodes that fit<br>over users face<br>that delivers<br>electrical<br>stimulation<br>connected to a<br>control unit. | Handheld<br>portable device<br>with electrodes,<br>batteries and<br>user controls. |
| User Interface | LCD Touch Screen on<br>main Control Unit with<br>Power Source and<br>Microprocessor<br>controlled | LCD Touch Screen<br>on main Control<br>Unit with Power<br>Source and<br>Microprocessor<br>controlled | Control Unit<br>with Power<br>Source and<br>Microprocessor<br>controlled. | LEDs and<br>switches |
| Compliance with<br>Voluntary Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>ISO 14971<br>IEC 62366 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>ISO 14971<br>IEC 62366 | Not Available | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>ISO 14971<br>IEC 62366 |
| Compliance with 21<br>CFR 898 | YES | YES | YES | YES |
| Power Sources | Mains Power 110 -<br>120, 220 - 240 VAC,<br>50- 60 Hz | Mains Power<br>100-240V, 50-60<br>Hz | 9V battery | Two 1.5 V AA<br>batteries |
| Patient leakage<br>current: Normal<br>Condition | Compliant with IEC<br>60601-1 leakage<br>current requirements | Compliant with IEC<br>60601-1 leakage<br>current<br>requirements | Not Available | Compliant with<br>IEC 60601-1<br>leakage current<br>requirements |
| Method of Channel<br>Isolation | Compliant with IEC<br>60601-1 isolation<br>requirements | Compliant with IEC<br>60601-1 isolation<br>requirements | Electrode Group<br>selected by<br>relays | Compliant with<br>IEC 60601-1<br>isolation<br>requirements |
| Synchronous or<br>Alternating Output | Both | Both | Alternating | Not Available |
| Software / Firmware<br>/ Micro-Processor<br>Control? | Yes | Yes | Yes | Yes |
| Number of Output<br>Modes | 1 | 1 | 1 | 4 |
| Specifications | Subject Device | Primary<br>Predicate Device | Reference<br>Predicate<br>Device # 1 | Reference<br>Predicate<br>Device # 2 |
| Regulated Current or<br>Regulated Voltage | Regulated Voltage | Regulated Voltage | Regulated<br>Voltage | Regulated<br>Voltage |
| Housing Materials<br>and Constructions | Molded PC-ABS<br>plastic material with<br>screw assembly<br>construction. | PCBs and leads<br>inside plastic, or<br>foam case housing. | ABS Plastic,<br>latch assembly | PCBs inside<br>plastic case<br>housing |
| Energy Type | Electrical Stimulation | Electrical<br>Stimulation | Electrical<br>Stimulation | Electrical<br>Stimulation |
| Voltage Current Level | Yes - Uncalibrated<br>Knob | Yes | Yes -<br>Uncalibrated<br>Knob | Not Available |
| Handpiece<br>Dimensions | Handpiece #1: 62mm x<br>147 mm<br>Handpiece #2: 39mm x<br>139.5 mm | 38.98" x 53.94" x<br>34.65" | 4.5" X 3" X<br>1.25" | 2.6" X 4.7" X<br>1.35" |
| Handpiece Weight | Handpiece #1: 1100 g<br>Handpiece #2: 720 g | 2500 g | 80 grams | 5.4 oz. |
| Recommended<br>Treatment Time/<br>Timer range | 20 Minutes<br>Recommended<br>Treatment Time | 20 Minutes Timer<br>range | 20/16 minutes<br>Timer Range | Not Available |
| Output Modes | 1 | 1 | 1 | 4 |
| Automatic Shut Off | YES | Unknown | YES | YES |
| Patient Contact | YES | YES | YES | YES |
| Contact Material | Stainless Steel 304<br>PMMA | Conductive Ink<br>(Silver) | PCB Mask with<br>Gold Plated<br>Brass Electrodes | Stainless Steel<br>316 |
| Waveform Shape | Pulsed Biphasic<br>rectangular modulated<br>by trapezoidal | Pulsed Biphasic<br>rectangular<br>modulated by<br>trapezoidal | Pulsed Biphasic<br>rectangular | Positive square<br>wave followed<br>by a damped<br>sinusoidal<br>waveform of<br>variable<br>duration<br>depending on<br>damping and<br>body loading |
| Max output voltage<br>[V] (±20%) at<br>500 Ω<br>2,000 Ω<br>10,000 Ω | 30V @ 500 Ω<br>33V @ 1,000 Ω | BTL-785-2, -8, -9<br>Max. 48,5V @ 10 -<br>373 Ω<br>48,5V @ 500 Ω<br>48,5V @ 2,000 Ω<br>0 @ 10,000 Ω | 18V @ 500 Ω<br>24V @ 1,000 Ω | 42V @ 500 Ω |
| Specifications | Subject Device | Primary<br>Predicate Device | Reference<br>Predicate<br>Device # 1 | Reference<br>Predicate<br>Device # 2 |
| | 35V @ 10,000 Ω | BTL-785-1, -7<br>Max. 48,5V @ 10 -<br>757 Ω<br>48,5V @ 500 Ω<br>48,5V @ 2,000 Ω<br>0 @ 10,000 Ω | 28V @ 10,000 Ω | 122V @ 2,000 Ω<br>348V @ 10,000 Ω |
| Max output current<br>(+/-20%) a<br>500 Ω<br>2,000 Ω<br>10,000 Ω | 60 mA @ 500 Ω<br>33 mA @ 1000 Ω<br>3.5 mA @ 10,000 Ω | BTL-785-2, -8, -9<br>Max. 130 mA @ 10<br>- 373 Ohm<br>97 mA @ 500 Ω<br>24 mA @ 2000 Ω<br>0 mA @ 10000 Ω<br>BTL-785-1, -7<br>Max. 64 mA @ 10 -<br>757 Ω<br>64 mA @ 500 Ω<br>24 mA @ 2000 Ω<br>0 mA @ 10000 Ω | 37.6 mA @ 500 Ω<br>12.4 mA @ 1000 Ω<br>2.8 mA @<br>10,000 Ω | Max. 0.5 mA<br>0.363 mA @<br>500 Ω<br>0.117 mA @<br>2000 Ω<br>0.038 mA @<br>10000 Ω |
| Max current density at<br>500 Ω [μA/mm²] | 82 µA/mm² | BTL-785-2 - 243<br>μA/mm²<br>BTL-785-8 - 335<br>μA/mm²<br>BTL-785-9 - 277<br>μA/mm²<br>BTL-785-1 - 168<br>μA/mm²<br>BTL-785-7 - 337<br>μA/mm² | 464 μA/ mm² | Built-in, Y<br>Brush: 8<br>μA/mm²<br>Pencil: 190<br>μA/mm² |
| Max average power<br>density at 500 Ω<br>[W/cm²] | 0.012W/ cm² | BTL-785-2 - 0.047<br>W/cm²<br>BTL-785-8 - 0.065<br>W/cm²<br>BTL-785-9 - 0.054<br>W/cm²<br>BTL-785-1 - 0.033<br>W/cm²<br>BTL-785-7 - 0.065<br>W/cm² | 0.0023 W/ cm² | Built-in, Y<br>Brush: 0.0005<br>W/cm²<br>Pencil: 0.0035<br>W/cm² |
| Net Charge per pulse | 0 µC (Pulse is biphasic<br>symmetrical) | 0 µC (Pulse is<br>biphasic<br>symmetrical) | 0 µC | 4 µC |
| Max phase charge per<br>pulse at 500 Ω [μC] | 23 µC | BTL-785-2, -8, -9<br>15 µC | 11.3 µC | 10 µC |
| Specifications | Subject Device | Primary<br>Predicate Device | Reference<br>Predicate<br>Device # 1 | Reference<br>Predicate<br>Device # 2 |
| | | BTL-785-1, -7<br>10 μC | | |
| Duration of primary<br>[μs]<br>(depolarizing phase) | 128 μs, 256 μs, 384 μs | 80 μs | Not Available | 500 μs |
| Pulse Duration [μs] | 128 μs, 256 μs, 384 μs | 160 μs | 300 μs | 1100 μs |
| Frequency [Hz] | 1 ~ 63 Hz | 250 Hz | 8 Hz | 15-121 Hz |

## 7. Substantially Equivalent (SE) Comparison

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## Similarities

The subject device is similar to the predicate product in:

- same classification information,
- same indications and intended use,
- same principle of operation
- same performance effectiveness and performance safety as the primary predicate device. ●
- same waveform shape
- . same maximum average power density
- substantially equivalent maximum output voltage
- substantially equivalent output current .

## Differences

The differences do not affect the performance and effectiveness of the subject device. Differences in Maximum Voltage, Maximum Current, Frequency, Pulse Duration, Phase Charge, and Current Density do not affect the performance and safety of the subject device.

Therefore, the MyoLight Microcurrent Handpiece device is substantially equivalent to the predicate device.

#### 8. Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:

- > IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2:2014/EN 60601-1-2:2015, Medical electrical equipment- Part 1-2: General requirements for basic A safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
- > IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
- > Biocompatibility Tests per ISO 10993 and FDA Guidance.
- > Software Validation & Verification Test.
- > Bench Testing to verify the performance.

#### 9. Clinical Testing

Not Applicable

## 10. Conclusion

Based on the comparison and analysis above, the proposed subject device is Substantially Equivalent (SE) to the predicate device.