LED Facial Mask

K230351 · Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. · OHS · May 5, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230351
• Device Name: LED Facial Mask
• Applicant: Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: May 5, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

Device Story

LED Facial Mask is an OTC, mask-shaped light therapy device for facial use. It utilizes LEDs to emit red (625nm), amber (605nm), and blue (465nm) light. The device comprises a mask body, a controller for power and color selection, and an AC adapter. Users place the mask over the face and operate it via the controller; the device features an automatic shut-off after treatment. The light energy is intended to reduce the appearance of wrinkles and treat mild to moderate acne. The device is intended for home use by the patient.

Clinical Evidence

Bench testing only. Biocompatibility testing (ISO 10993-5, ISO 10993-10) for ABS and PC plastic components passed. Electrical safety and electromagnetic compatibility testing (IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-57) and photobiological eye safety (IEC 62471) passed.

Technological Characteristics

Materials: ABS and PC plastic. Energy: LED-based light therapy (Red 625nm, Amber 605nm, Blue 465nm). Power: External AC adapter (100-240V). Form factor: Facial mask. Connectivity: None. Standards: ISO 10993-1/5/10, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62471.

Indications for Use

Indicated for treatment of wrinkles and mild to moderate inflammatory acne on the face in an over-the-counter setting.

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

• Skin Care Beauty Mask /MJ-06 (K220168)

Reference Devices

• Aduro light therapy Handheld/HD-03A (K203271)
• MMSphereTM (K190443)

Submission Summary (Full Text)

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May 5, 2023

Shenzhen SUNGPO HI-TECH Electronic Co., Ltd % Rain Yip Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 ZhenYe International Center, No. 3101-90 Qianhai Road, Nanshan District Shenzhen, Guangdong 518000 China

Re: K230351

Trade/Device Name: LED Facial Mask 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, OLP Dated: January 16, 2023 Received: February 9, 2023

Dear Rain Yip:

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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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.

Colin K. Chen -S

for

Jianting Wang Acting 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)

Device Name

LED Facial Mask, Model(s): MZ-01, NEWKEY-01, SP-FM-01

Indications for Use (Describe)

LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

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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# 510(k) Summary K230351

#### "510(k) Summary" as required by 21 CFR Part 807.92.

#### Date: 2023-01-16

#### I. Submitter

Shenzhen SUNGPO HI-TECH Electronic Co.,Ltd 806 Chuangke Building, No.72-6 Huanguan South Road, Xintian Community, Guanhu Street, Longhua District, Shenzhen city, China Post code: 518000 Tel .: [phone]

Ava Hu General Manager Tel: [phone] Email: [e-mail]

#### II. Device

Name of Device: LED Facial Mask Model(s): MZ-01, NEWKEY-01, SP-FM-01 Classification name: Light Based Over The Counter Wrinkle and Acne Reduction Common Name: Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based For Acne Regulatory Class: II Product Code: OHS, OLP Review Panel: General & Plastic Surgery Regulation Number: 21 CFR 878.4810

#### III. Predicate Device

| Predicate device | Predicate device | Reference device #1 | Reference device #2 |
|--------------------------|-----------------------------------|----------------------------------------|----------------------|
| 510(k) number | K220168 | K203271 | K190443 |
| Sponsor | Shenzhen Kaiyan<br>Medical Co Ltd | Shenzhen Kaiyan<br>Medical CO LTD | Galactic Beauty, LLC |
| Device name<br>and model | Skin Care Beauty Mask<br>/MJ-06 | Aduro light therapy<br>Handheld/HD-03A | MMSphereTM |
| Product code | OHS, OLP | OHS, OLP | OHS, OLP |
| Approval date | May 17, 2022 | July 21, 2021 | June 24, 2019 |

#### IV. Device Description

The LED Facial Mask is an over-the-counter, facemask-shaped design light emitting diode (LED) device that emits light energy in the red, blue, and amber spectrum for the treatment of wrinkles

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or mild to moderate inflammatory acne on the face. The device consists of a mask body unit, controller, and AC adapter. The mask body unit contains light emitting diodes (LEDs) that emit visible red light (650nm+/-5nm), amber light (605nm+/-5nm), or blue light (465nm+/-5nm) to help reduce the appearance of wrinkles or mild to moderate acne. A controller is connected to the mask body unit to control the device, such as turn on/off the device, switch LED color output. An AC adapter is used to power the device. To use the device, user should place the mask body unit over the face and use the controller to operate. The device will automatically turn off after each treatment.

The LED Facial Mask includes MZ-01, NEWKEY-01, and SP-FM-01 models. Their intended use, performance, structure design, and operation are identical, with the difference being the product appearance, but these differences do not affect or change the intended use of the device.

### V. Indications for Use

LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

## VI. Comparison of Technological Characteristics With the Predicate Device

Compare with predicate devices, the subject device LED Facial Mask is very similar to or in the same design principle, intended use, functions, materials, and the applicable standards. The differences between subject device and the predicate devices do not raise new questions of safety or effectiveness.

| Comparison<br>Elements | Subject Device | Predicate device | Reference device<br>#1 | Reference device<br>#2 |
|-------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name | LED Facial Mask/<br>MZ-01, NEWKEY-<br>01, SP-FM-01 | Skin Care Beauty<br>Mask /MJ-06 | Aduro light therapy<br>Handheld/HD-03A | MMSphere™ |
| 510(k) number | K230351 | K220168 | K203271 | K190443 |
| Product code | OHS, OLP | OHS, OLP | OHS, OLP | OHS, OLP |
| Classification<br>name | Light Based Over<br>The Counter Wrinkle<br>and Acne Reduction | Light Based Over<br>The Counter<br>Wrinkle Reduction<br>(OHS) Over-The-<br>Counter Powered<br>Light Based Laser<br>For Acne (OLP) | Light Based Over<br>The<br>Counter<br>Wrinkle and Acne<br>Reduction | Light Based Over<br>The Counter Acne<br>and<br>Wrinkle<br>Reduction |
| Indication for<br>device | LED Facial Mask is<br>an over the counter<br>device that is<br>to | The Skin Care<br>Beauty Mask<br>(Model: MJ 06) | The Aduro light<br>therapy Handheld<br>(Model: HD 03A) | MMSphere™<br>Light Therapy<br>Device emits<br>to |
| Comparison<br>Elements | Subject Device | Predicate device | Reference<br>device<br>#1 | Reference device<br>#2 |
| | acne. | indicated to treat<br>full face wrinkles<br>and/or mild to<br>moderate acne. | wrinkles, and the<br>blue light is<br>intended for the<br>treatment of the<br>mild to moderate<br>inflammatory acne. | specifically<br>indicated to treat<br>wrinkles and/or<br>mild to moderate<br>acne.<br>The MMSphere™<br>is designed to be<br>used for 20<br>minute treatments<br>three to seven<br>times per week. |
| Location for use | Face | Face | Face | Face |
| Treatment time | 10 minutes/day, 3<br>times per week | 5 or 10<br>minutes/day, 3<br>times per week | 3-5 minutes on<br>each treatment<br>area. For best<br>results 3-5 times<br>per week with 2<br>day rest. | 20mins/day,<br>120days |
| Environment<br>for use | OTC | OTC | OTC | OTC |
| Power supply | An external adapter<br>Input: AC 100-240V<br>50-60Hz 0.2A<br>Output: DC 12V<br>0.5A | Adapter:<br>Input: 100-<br>240Va.c., 50/60Hz,<br>0.5A<br>Output: 5.0Vd.c.,<br>2.0A | 2600mAh, 3.7V Li<br>battery | Not publicly<br>available |
| Irradiance<br>source | Light emitting diodes<br>(LEDs) | Light emitting<br>diodes (LEDs) | Light emitting<br>diodes (LEDs) | Light emitting<br>diodes (LEDs) |
| LED<br>Wavelengths | Blue: 465nm±5nm<br>Red: 625nm±5nm<br>Amber: 605nm±5nm | Blue: 465nm±10nm<br>Red: 640nm±10nm | Blue: 415nm±10nm<br>Red: 630nm±10nm<br>IR: 850nm | Amber: 605nm<br>Red: 625nm<br>Blue: 465nm |
| LED<br>Power<br>density | Blue: 15~63mW/cm²<br>Red: 31~75mW/cm² | Blue: 30mW/cm²<br>Red: 30mW/cm² | Blue:<br>20~65mW/cm²<br>Red:<br>40~80mW/cm² | Blue:<br>1.33mW/cm²<br>Red:<br>2.45mW/cm² |
| Material<br>of<br>device<br>and<br>construction | ABS and PC plastic | Not publicly<br>available | ABS plastic | Not publicly<br>available |
| Biocompatibility feature | Comply with<br>ISO10993-1,<br>ISO10993-5 and<br>ISO10993-10 | Comply with<br>ISO10993-1,<br>ISO10993-5 and<br>ISO10993-10 | Comply with<br>ISO10993-1,<br>ISO10993-5 and<br>ISO10993-10 | Comply with<br>ISO10993-5 and<br>ISO10993-10 |
| Comparison<br>Elements | Subject Device | Predicate device | Reference device<br>#1 | Reference device<br>#2 |
| Compliance<br>with voluntary<br>standards | IEC60601-1-2 | IEC60601-1-2 | | IEC60601-1-2 |
| | IEC60601-1 | IEC60601-1 | | IEC60601-1 |
| | IEC60601-1-11 | IEC60601-1-11 | Not publicly<br>available | IEC60601-1-11 |
| | IEC60601-2-57 | IEC60601-2-57 | | IEC60601-2-57 |
| | IEC62471 | IEC62471 | | IEC62471 |

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### VII.Performance Data

The following performance data were provided in support of the substantial equivalence determination.

### 1) Biocompatibility Safety

The materials of the patient-directly contacting components of the LED Facial Mask is ABS and PC plastic and performed the biocompatibility evaluation in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document issued on Sep. 4, 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:

- > ISO 10993-5 Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
- > ISO 10993-10 Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization

## 2) Electrical Safety and Eye Safety

Electrical safety and Eye safety testing was performed to, and passed, the following standards:

- > IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- > IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- > IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- > IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

#### 3) Eve Safety

- > IEC 62471 Photobiological safety of lamps and lamp systems
#### 4) Software Verification and Validation

Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. Summary

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Based on the above performance as documented in this application, the LED Facial Mask was found to have a safety and effectiveness profile that is similar to the predicate device.

#### VIII. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the LED Facial Mask is to be concluded substantial equivalent to its predicate device.