Luna 4 plus

K241102 · Foreo, Inc. · OHS · Aug 20, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K241102
• Device Name: Luna 4 plus
• Applicant: Foreo, Inc.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Aug 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Luna 4 plus is a Near-Infrared Heated Cleansing Device with Red LED/NIR light & Microcurrent Massage Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles

Device Story

Luna 4 plus is a handheld, battery-powered, over-the-counter cosmetic device for home use. It combines two primary modalities: microcurrent electrical therapy for facial stimulation and red/NIR LED light therapy for periorbital wrinkle reduction. The device features two microcurrent pins on the back for targeted toning massage. An integrated controller manages device operation, including power and mode selection. Safety features include a thermal sensor and heat stabilizer to maintain skin temperature between 42°C-43°C, and an Anti-Shock system that monitors voltage via a feedback resistor to ensure stable current output. The device is operated by the user. The healthcare provider does not interact with the device output; the user observes the cosmetic effects of the treatment. The device benefits the patient by providing non-invasive facial toning and wrinkle reduction in a home setting.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-5, -10, -23), and performance testing of the Anti-Shock system and electrical stimulation output under overload conditions. Usability studies were conducted to support the OTC indications.

Technological Characteristics

Materials: body-safe silicone, ABS plastic, copper, glass, gold, zinc alloy. Energy: internal rechargeable Li-battery. Modalities: Microcurrent (pulsed monophasic, charge-balanced) and Red/NIR LED (633nm/850nm). Safety: thermal sensor/stabilizer (42-43°C limit), Anti-Shock system. Connectivity: none. Software: embedded firmware for output control and safety monitoring. Sterilization: N/A (non-sterile).

Indications for Use

Indicated for OTC cosmetic use in adults for facial stimulation (via microcurrent) and treatment of periorbital wrinkles (via red/NIR light).

Regulatory Classification

Identification

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

Predicate Devices

• EP-300 (K162652)
• TheraFace LED (K212155)
• Nuface Trinity ELE Plus Pro (K201906)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.

August 20, 2024

Foreo Inc. % Danijela Domljanovic Consultant DD Consulting 401-4080 Living Arts Drive Mississauga, ON L5B 4N3 Canada

Re: K241102

Trade/Device Name: Luna 4 plus Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS, NFO Dated: April 16, 2024 Received: April 22, 2024

Dear Danijela Domljanovic:

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

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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" (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-devices/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).

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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-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -S Date: 2024.08.20
19:33:18 -04'00'

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

Enclosure

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# Indications for Use

510(k) Number (if known) K241102

Device Name Luna 4 plus

Indications for Use (Describe)

Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED/NIR light & Microcurrent Massage.

Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# K241102 - LUNA 4 plus 510(k) Summary

| Date Prepared: | 08/20/2024 |
|---------------------------------|----------------------------------------------------------------------------------------|
| 510(k) Submitter: | FOREO, Inc.<br>1525 E. Pama Lane<br>Las Vegas, NV 89119 |
| Contact: | Danijela Domljanovic<br>E: [e-mail]<br>P: 647-928-6919 |
| Device Names: | |
| Device Trade/ Proprietary Name: | Luna 4 plus |
| Common or Usual Name: | Luna 4 plus |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology |
| Regulation Number: | 21 CFR 890.4810<br>21 CFR 882.5890 |
| Product Code: | OHS, NFO |

## Predicate Device:

The legally marketed predicate devices to which FOREO, Inc. is claiming equivalence for over-the-counter use:

| 510(k) Number: | K162652 |
|----------------|---------------------------------------------|
| Manufacturer: | Guangzhou LETA Testing Technology Co., Ltd. |
| Product Code: | OHS, NFO, OLP |

510(k) Number: K201906 Carol Cole Company dba NuFACE Manufacturer: Product Code: NFO

| 510(k) Number: | K212155 |
|----------------|---------------|
| Manufacturer: | Theragun, Inc |
| Product Code: | OHS, OLP, IRC |

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## Device Description:

Luna 4 plus has multiple functions combined in a single device, like RED+NIR LED Treatment for wrinkle reduction

The device emits visible red/IR light (Red: 630nm +/- 10nm.) for elevating tissue temperature in improving appearance of facial wrinkles.

Microcurrent to target facial stimulation

Two microcurrent pins at the back for a targeted toning massage, emitting microcurrent electrical therapy to deliver skin stimulation where maximum power delivered to the load is controlled and limited by integral software.

Luna 4 plus is a single device powered by a rechargeable battery. A controller is integrated on the back to control the device, such as turn on/off the device, mode buttons.

Rechargeable Li-battery contained in the controller with a USB cable accessible to target it. To user should use the controller to operate.

## Intended Use:

Luna 4 plus is a Near-Infrared Heated Cleansing Device with Red LED/NIR light & Microcurrent Massage

Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles

## Technological Characteristics:

LUNA 4 plus is substantially equivalent to that of its technological characteristics remain unchanged.

## Non-Clinical Testing:

To establish substantial equivalence to the predicate devices, LUNA 4 Plus was tested to the applicable standards for electrical safety, EMC, and biocompatibility, as listed in the Substantial Equivalence Comparison Table below. Additionally, LUNA 4 Plus underwent lab bench performance testing to characterize its electrical stimulation output, including performance testing of the Anti-Shock System and performance under overload conditions. Usability studies conducted demonstrate that the device is substantially equivalent to the predicate given the new indications.

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## Performance Standards:

Luna 4 plus is substantially equivalent to that of its predicates and complies to FDA performance standards set forth in 21 CFR §898.

Product Safety and EMC performance testing was conducted for the following aspects:

- ി . Electrical and Constructional Safety in accordance with IEC 60601-1
- 2. Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2

Thus, with respect to Safety and EMC, Luna 4 plus is substantially equivalent to its predicates.

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# Table 1: Substantial Equivalence Comparison Table

| Features | Subject Device | Predicate | Predicate Device | Predicate Device | Remarks |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Regulatory Information | | | | | |
| Device Name | Luna™ 4 plus | EP-300 | TheraFace LED | Nuface Trinity ELE<br>Plus Pro | / |
| 510(K) No. | Applying | K162652 | K212155 | K201906 | / |
| Regulation<br>Number | 878.4810<br>882.5890 | 882.5890 | 878.4810 | 882.5890 | Different |
| Regulation<br>name | Laser surgical<br>instrument for use in<br>general and plastic<br>surgery and in<br>dermatology | Transcutaneous<br>Electrical Nerve<br>Stimulator for Pain<br>Relief | Laser surgical<br>instrument for use<br>in general and<br>plastic surgery<br>and in dermatology | Transcutaneous<br>Electrical Nerve<br>Stimulator for Pain<br>Relief | Different |
| Regulatory<br>Class | II | II | II | II | Same |
| Product Code | OHS, NFO | OHS,NFO,OLP | OHS, OLP, IRO | NFO | Similar |
| Intended Use | 1.The Red + IR light is<br>intended to treat<br>periorbital wrinkles<br>2.The microcurrent is<br>intended to treat<br>facial stimulation | (1) The EMS mode is<br>indicated for facial<br>stimulation;<br>(2) The Photon mode:<br>The red light is<br>intended for the<br>treatment of<br>periorbital wrinkles<br>and the blue light is<br>intended for the<br>treatment of the mild<br>to moderate<br>inflammatory acne | The device can<br>work in multiple<br>function modes as<br>following with<br>different indication<br>for use:<br>1.The red light is<br>intended to treat<br>periorbital<br>wrinkles.<br>2.The blue light is<br>intended to treat<br>mild to moderate<br>inflammatory acne.<br>3.The Red + IR is<br>intended to treat<br>periorbital<br>wrinkles. | The Trinity ELE Plus<br>Pro devices are<br>intended for facial<br>stimulation and<br>indicated for over-<br>the-counter<br>cosmetic use. | Similar |
| Indications for<br>Use | OTC Cosmetic Use | OTC Cosmetic Use | OTC Cosmetic Use | OTC Cosmetic Use | Same |
| Safety<br>mechanism | Thermal sensor and<br>heat stabilizer: These<br>measure the skin<br>temperature, stabilize<br>the heat energy and<br>prevent overheating.<br>When the skin<br>temperature reaches<br>42°C - 43°C, the<br>stabilizer will<br>automatically stop<br>emitting heat, until<br>the skin temperature<br>lowers enough for the<br>stabilizer to resume<br>heating.<br><br>Anti-Shock system:<br>Detect the current<br>through the skin by<br>monitoring voltage on<br>the feedback resistor,<br>and feedback to the<br>microprocessor to<br>ensure the current<br>keeps relatively stable<br>and smooth. | Unknown | The device has an<br>automatic reset<br>thermal<br>limiter that shuts<br>off the device to<br>prevent<br>overheating and<br>fire | Unknown | Different |
| Device Characteristics | | | | | |
| Apply Parts | Face | Face | Face | Face | Same |
| Treatment<br>regimen | Yes (1-4 min)<br>(adjustable) | Yes (10 mins) | Red light: 5 - 7<br>minutes per<br>treatment zone<br>Red+IR: 5 - 7<br>minutes per<br>treatment zone | Yes (21 mins) | Different |
| Use<br>Environment | Home Use, lay users | Home Use, lay users | Home Use, lay<br>users | Home Use, lay<br>users | Same |
| Power Source(s) | Internal rechargeable<br>Lithium battery | Internal rechargeable<br>Lithium battery | Internal<br>rechargeable<br>Lithium battery | Internal<br>rechargeable<br>Lithium battery | Same |
| Maximum<br>charging time | 2 hours | Unknown | 1 hour | 12 hours | Different |

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| Indi<br>cato<br>r for<br>Disp<br>lay | On/off | Yes | Yes | Yes | Yes | Same | |
|-------------------------------------------------|------------------|-------------------------------------------------------------------|----------------------|------|---------------------------------------|---------------------|--|
| | Low-<br>battery | Yes | Yes | Yes | Yes | Same | |
| | Current<br>level | Yes | Yes | Yes | Yes | Same | |
| Regulated<br>Current or<br>Regulated<br>Voltage | | Regulated Voltage | Regulated Voltage | Both | Both | Similar | |
| Software/Firmw<br>are/ control | | Yes | Yes | Yes | Yes | Same | |
| Automatic<br>Overload Trip | | Not required due to<br>circuit design | Yes | Yes | Not required due<br>to circuit design | Similar | |
| Automatic Shut<br>Off | | Yes | Yes | Yes | Yes | Same | |
| Micro current Function | | | | | | | |
| Electrodes | | 1 | 2 | N/A | 1 | Similar | |
| Method of line<br>current<br>isolation | | Type BF | Type BF | N/A | Type BF | Same | |
| Patient leakage current | | | | | | | |
| Normal<br>condition | | N/A-Battery operated | N/A-Battery operated | N/A | N/A-Battery<br>operated | Same | |
| Single fault<br>condition | | N/A-Battery operated | N/A-Battery operated | N/A | N/A-Battery<br>operated | Same | |
| Number of<br>output channels | | 1 | 1 | N/A | 1 | Same | |
| Synchronous or<br>alternating | | N/A-1 Output channel | N/A-1 Output channel | N/A | N/A-1 Output<br>channel | Same | |
| Method of<br>channel<br>isolation | | N/A-1 Output channel | N/A-1 Output channel | N/A | N/A-1 Output<br>channel | Same | |
| Patient override<br>control | | Yes | Yes | N/A | Yes | Same | |
| Waveform | | Pulsed monophasic,<br>alternating<br>polarity,<br>charge-balanced | Pulsed Biphasic | N/A | Pulsed Biphasic | Different<br>Note 2 | |

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| Waveform<br>shape | Modulated square | Rectangular | N/A | Modulated square | Different<br>Note 2 |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------|
| Pulse width<br>range | 290 µs | 4ms | N/A | Varies w/<br>Frequency<br>(60 msec @<br>8.33Hz) | Different<br>Note 2 |
| Maximum RMS<br>Output Voltage | 0.28V @500Ω<br>1.11V @2KΩ<br>5.50V @10KΩ | 1.49V @500Ω<br>2.48V @2kΩ<br>10.6V @10kΩ | N/A | 208 mV @ 500 Ω<br>840 mV @ 2 kΩ<br>4.3 V @ 10 kΩ | Different<br>Note 2 |
| Maximum RMS<br>output Current | 560μA @500Ω<br>555μΑ @2ΚΩ<br>552μA @10KΩ | 2.98mA @500Ω<br>1.24mA @2kΩ<br>1.06mA @10kΩ | N/A | 297 μΑ @ 500 Ω<br>299 μΑ @ 2 κΩ<br>301 μΑ @ 10 κΩ | Different<br>Note 2 |
| Maximum RMS<br>Current Density | 1.37 mA/cm² @500 Ω | 0.524mA/cm² @500 Ω | N/A | 1.165 mA/cm²<br>@10K Ω | Different<br>Note 2 |
| Maximum RMS<br>Power Density | 0.38 mW/cm² @500 Ω | 0.216 mW/cm² @500 Ω | N/A | 3.525 mW/cm²<br>@10K Ω | Different<br>Note 2 |
| Frequency<br>Range | 46Hz | 60Hz | N/A | 0.3 — 50 Hz<br>(Default 8.3 Hz) | Different<br>Note 2 |
| Output<br>tolerance | +/- 10% (RMS) | unknown | N/A | +/- 10% (RMS) | Same |
| Maximum Net<br>Charge | 0 µC(charge-balanced) | 0 µC | N/A | N/A - Battery<br>Operated | Different<br>Note 2 |
| Maximum RMS<br>phase charge<br>per burst | 0.16μC@ 500Ω | Unknown | N/A | 18.17 μC @ 10K Ω | Different<br>Note 2 |
| Maximum RMS<br>charge density | 0.39μC/cm2 | Unknown | N/A | Unknown | Different<br>Note 2 |
| Output RMS<br>current when<br>not simulating | <1 μΑ | Unknown | N/A | Unknown | Different<br>Note 2 |
| For interferential modes, only | | | | | |
| a. Beat<br>Frequency<br>(Hz) | No Beat Frequency | Unknown | N/A | No Beat Frequency | Same |
| For multiphasic waveforms, only | | | | | |
| Symmetrical<br>phases | Not Multiphasic | Unknown | N/A | Not Multiphasic | Same |
| b. Phase<br>Duration<br>(include units)<br>c. (state range, if applicable)<br>d. (both phases, if asymmetrical) | No Beat Frequency | Unknown | N/A | No Beat Frequency | Same |
| Burst mode information | | | | | |
| a. Pulses per<br>burst | 2 | Unknown | N/A | 20 | Different<br>Note 2 |
| b. Pulses per<br>second | 100 | Unknown | N/A | varies w/<br>Frequency<br>(8.3 @8.33Hz) | Different<br>Note 2 |
| c. Burst<br>duration (sec) | 0.02 | Unknown | N/A | Varies w/<br>Frequency<br>(2.4 @ 8.33Hz) | Different<br>Note 2 |
| d. Duty Cycle<br>(%) | NA | Unknown | N/A | 50 | Different<br>Note 2 |
| On time(sec) | 372 μs | Constant | N/A | Varies w/<br>Frequency<br>(60ms @ 8.33Hz @<br>50% Duty Cycle) | Different<br>Note 2 |
| Off time(sec) | 10.12 ms | None | N/A | Varies w/<br>Frequency<br>(60ms @ 8.33Hz @<br>50% Duty Cycle) | Different<br>Note 2 |
| For LED Red and NIR Light Irradiation function | | | | | |
| Visible LED<br>Wavelength | RED light:<br>633nm±10nm<br>Red+IR: 633±10nm /<br>850nm±10nm | Red-light:<br>630±10nm<br>Blue light:<br>415±10nm | Red light:<br>633nm±10nm<br>Red+IR: 633±10nm<br>/830nm±10nm | N/A | Different<br>Note 3 |
| Optical Power<br>Density | RED+IR:63 mW/cm² | Red light:<br>80 mW/cm2<br>Blue light:<br>50mW/cm2 | Red light:<br>73±5 mW/cm²<br>Red+IR:<br>73±5/55±5<br>mW/cm² | N/A | Different<br>Note 3 |
| Additional Features | | | | | |
| Weight | 150g | 125g | 230g | 180g | Different<br>Note 4 |
| Dimensions<br>(mm) | 82*38*102 mm | 140.5 x 61 x 76 mm | 140*65*55 mm | 127*76*25mm | Different<br>Note 4 |
| Housing<br>material and<br>construction | Body-safe silicone,<br>ABS plastic, copper,<br>glass, gold, zinc alloy | Console: ABS plastic | PC Plastic &<br>Stainless Steel | ABS<br>Thermoplastic,<br>Chromium | Similar |
| User interface | Power button on/Off<br>Deep cleansing mode<br>button<br>Regular cleansing<br>mode button | Power button on/Off<br>Switch button<br>Shift Adjust Intensity<br>LCD Screen<br>Photon Light | Power Button<br>Percussive Therapy<br>Button<br>Ring button<br>RED+IR LED Ring | multi-function<br>button on/off<br>BOOST button<br>Release Button<br>Power down/up<br>button | Similar |
| Environment<br>for operating | Temperature:<br>5 ~ 40° C<br>Relative humidity:40%<br>~ 80% | Temperature:<br>5~ 40° C<br>Relative humidity:<br><93% RH | Temperature:<br>0 ~ 40° C<br>Relative humidity:<br><93% RH | Temperature:<br>10 ~ 40° C<br>Relative<br>humidity:30~<br>75%rH | Similar |
| Environment<br>for storage | Temperature:<br>-10 ~ 50° C<br>Relative humidity:<br>30%~ 80% | Temperature:<br>-25° C ~ 50° C<br>Relative humidity:<br>10~95% RH | Temperature:<br>-25 ~ 50° C<br>Relative humidity:<br>10~95% | Temperature: -10 ~<br>55°C<br>Relative humidity:<br>10~90% | Similar |
| Biocompatibility | ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23 | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | Similar |
| Electrical Safety | IEC 60601-1<br>IEC 60601-1-6<br>IEC 60601-1-11<br>IEC 60601-2-10<br>IEC 60601-2-57 | IEC 60601-1<br>IEC 60601-2-10 | IEC 60601-1,<br>IEC 60601-1-11<br>IEC 60601-2-57<br>IEC 62471 | IEC 60601-1 | Similar |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Compliance<br>with 21 CFR 898 | Yes | Yes | Yes | Yes | Same |

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## Comparison in details

## Note 1:

The power supply for the subject device is different from that of the predicate device, however the lithium battery of the subject device has been tested under standard IEC 62133-2, so this difference should not raise any safety/effectiveness questions.

## Note 2:

Though the electrical microcurrent stimulation characteristics of the LUNA 4 Plus (including effective area, pulse width range, burst characteristics, and total output power density) differ slightly from the predicate devices, these differences are intended to provide improved user experience and do not significantly affect the subject device's safety and effectiveness relative to the predicates. In particular, the LUNA 4 Plus' output power density is lower than the secondary predicate (K201906), and adequate electrical safety and performance testing were conducted according to applicable standards for nerve and muscle stimulators (including IEC 60601-2-10) as well as lab bench performance evaluation.

## Note 3:

Although differences exist for LED wavelength and Optical Power Density, additional usability report and bench evaluation are performed to ensure its safety and effectiveness.

## Note 4:

Although the appearance, dimensions, and environment storage are different between the subject and predicate device, these differences have no impact and do not raise any safety/effectiveness problems.

## 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 the LUNA 4 plus is substantially equivalent to the EP-300, TheraFace LED and Nuface Trinity ELE Plus Pro with regards to safety and effectiveness.