Aduro Light Beauty Mask

K202390 · Shenzhen Kaiyan Medical CO , Ltd. · OHS · Jul 14, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202390
• Device Name: Aduro Light Beauty Mask
• Applicant: Shenzhen Kaiyan Medical CO , Ltd.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Jul 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For MK-660, MK-66USBO, MK-020: The Aduro Light Beauty Mask (MK-66O, MK-66USBO, MK-02O) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne. For MK-66USBA, MK-02A: The Aduro Light Beauty Mask (MK-66USBA, MK-02A) is intended to emit light in the blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face. For MK-66USBB, MK-02B: The Aduro Light Beauty Mask (Model: MK-66USBB, MK-02B) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

Device Story

Facemask-shaped light therapy device; applies red (640nm) and/or blue (465nm) light to face skin. 66 LEDs provide ~30mw/cm² intensity. User-operated; OTC use. Device features automatic 10-minute treatment timer. Powered by internal lithium battery or plug-in adapter. Intended to improve appearance of wrinkles and reduce mild to moderate acne. Benefits include non-invasive, home-based aesthetic treatment.

Clinical Evidence

Bench testing only. Safety and performance evaluated via electrical safety (IEC 60601-1, 60601-1-11, 60601-2-57), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10). No clinical data provided.

Technological Characteristics

Facemask form factor; 66 LEDs; wavelengths 465nm (blue) and 640nm (red); power density ~30mw/cm². Powered by 3.7V 2600mAh lithium battery or 100-240V AC adapter. Biocompatible materials per ISO 10993. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57.

Indications for Use

Indicated for treatment of full-face wrinkles and/or mild to moderate inflammatory acne on the face in adults.

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

• MMSphere (K190443)
• LED Therapy Device (K192295)
• FaceLITE (K191629)
• Neutrogena Light Therapy Acne Mask+ (K180847)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 14, 2021

Shenzhen Kaiyan Medical Co Ltd % Alain Dijkstra Manager SHENZHEN KAIYAN MEDICAL CO LTD. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510006 China

Re: K202390

Trade/Device Name: Aduro Light Beauty 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, ILY Dated: August 14, 2020 Received: August 21, 2020

Dear Alain Dijkstra:

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 post-marketing 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,

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K202390

Device Name

Aduro Light Beauty Mask (Model: MK-66USBQ, MK-66USBA, MK-66USBA, MK-020, MK-02A, MK-02B)

Indications for Use (Describe)

For MK-660, MK-66USBO, MK-020:

The Aduro Light Beauty Mask (Model: MK-660, MK-66USBO, MK-020) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.

For MK-66USBA, MK-02A:

The Aduro Light Beauty Mask (Model: MK-66USBA, MK-02A) is intended to emit light in the blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.

For MK-66USBB, MK-02B:

The Aduro Light Beauty Mask (Model: MK-66USBB, MK-02B) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary of K202390

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 878.4810.

### 1. Submitter's Information

Company Name: SHENZHEN KAIYAN MEDICAL CO LTD Establishment Registration Number: 3011644607 Address: 40A Fuxin Road, Fuyong Subdistrict, BaoAn District, Shenzhen Guangdong, China Contact Person (including title): Alain Dijkstra (CEO) Tel: [phone] Fax: [phone] E-mail: [e-mail]

### Application Correspondent:

Contact Person: Alain Dijkstra SHENZHEN KAIYAN MEDICAL CO LTD. Address: 40A Fuxin Road, Fuyong Subdistrict, BaoAn District, Shenzhen Guangdong, China Tel: [phone] Email: [e-mail]

### 2. Subject Device Information

Type of 510(k): Traditional Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over-The Counter Wrinkle Reduction (OHS) Trade Name: Aduro Light Beauty Mask Model Name: MK-660, MK-66USBO, MK-66USBA, MK-66USBB, MK-02O, MK-02A, MK-02B Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Regulatory Class: II

### 3. Predicate Device Information

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| Predicate<br>device | Predicate device<br>1 | Predicate device 2 | Predicate<br>device 3 |
|--------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Sponsor | Galactic Beauty,<br>LLC | Beijing ADSS Development<br>Co., Ltd. | ISMART<br>Marketing Svcs<br>Ltd |
| Device Name<br>and Model | MMSphere | LED Therapy Device | FaceLITE |
| 510(k) Number | K190443 | K192295 | K191629 |
| Classification<br>Name | Light Based Over-<br>The-Counter Acne<br>Treatment / Light<br>Based Over the<br>Counter Wrinkle<br>Reduction | Light Based Over-The-<br>Counter Acne Treatment /<br>Light Based over the Counter<br>Wrinkle Reduction | Light Based<br>Over-The-<br>Counter<br>Wrinkle<br>Reduction |
| Review Panel | General & Plastic<br>Surgery | General & Plastic Surgery | General &<br>Plastic Surgery |
| Product Code | OLP, OHS | OLP, OHS | OHS |
| Regulation<br>Number | 878.4810 | 878.4810 | 878.4810 |
| Regulation<br>Class | II | II | II |

#### 4. Device Description

For MK-660, MK-66USBO, MK-02O:

The Aduro Light Beauty Mask (Model: MK-660, MK-66USBO, MK-020) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies light onto the face skin surface. The Aduro Light Beauty Mask can emit light with two different center wavelengths. The blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) is intended to improve the appearance of wrinkles. There are a total of 66 LEDs to provide power intensity of about 30mw/cm2.

The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 10-minute treatment.

### For MK-66USBA, MK-02A:

The Aduro Light Beauty Mask (Model: MK-62A) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies specified light onto the face. The Aduro Light Beauty Mask can emit the blue light (465nm) which is intended to help reducing the appearance of mild to moderate inflammatory acne. There are a total of 66 LEDs to provide power intensity of about 30mw/cm².

The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 10-minute treatment.

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#### For MK-66USBB, MK-02B:

The Aduro Light Beauty Mask (MK-66USBB, MK-02B) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies specified light onto the face. The Aduro Light Beauty Mask can emit the red light (640nm) which is intended to improve the appearance of wrinkles. There are a total 66 LEDs to provide power intensity of about 30mw/cm². The user wears the mask on their face for the treatment, and the device will shut down automatically after

finishing a 10-minute treatment.

#### 5. Intended Use / Indications for Use

For MK-660, MK-66USBO, MK-020:

The Aduro Light Beauty Mask (MK-66O, MK-66USBO, MK-02O) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.

#### For MK-66USBA, MK-02A:

The Aduro Light Beauty Mask (MK-66USBA, MK-02A) is intended to emit light in the blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.

For MK-66USBB, MK-02B:

The Aduro Light Beauty Mask (Model: MK-66USBB, MK-02B) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

### 6. Non-clinical Testing

Aduro Light Beauty Mask (Model: MK-660, MK-66USBO, MK-66USBB, MK-02O, MK-02A, MK-02B) has been evaluated for safety and performance by testing as follows:

| Standards No. | Standard Title | Version | Date |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------|
| ES 60601-1 | Medical electrical equipment - Part 1:<br>General requirements for basic safety and<br>essential performance | 2005/(R)2012 and<br>A1:2012 | 07/09/2014 |
| Standards No. | Standard Title | Version | Date |
| IEC 60601-1-11 | Medical electrical equipment - Part 1-11:<br>General requirements for basic safety and<br>essential performance - Collateral<br>Standard: Requirements for medical<br>electrical equipment and medical electrical<br>systems used in the home healthcare<br>environment | Edition 2.0 2015-01 | 06/27/2016 |
| IEC 60601-2-57 | Medical Electrical Equipment - Part 2-57:<br>Particular requirements for the basic safety<br>and essential performance of non-laser<br>light source equipment intended for<br>therapeutic, diagnostic, monitoring and<br>cosmetic/aesthetic use | Edition 1.0 2011-01 | 03/16/2012 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and<br>essential performance - Collateral<br>Standard: Electromagnetic disturbances -<br>Requirements and tests | Edition 4.0 2014-02 | 09/17/2018 |
| IEC 62366-2 | Secondary cells and batteries containing<br>alkaline or other non-acid electrolytes -<br>Safety requirements for portable sealed<br>secondary cells, and for batteries made<br>from them, for use in portable applications<br>- Part 2: Lithium systems | Edition 1.0 2017-02 | 12/23/2019 |
| ISO 10993-5 | Biological evaluation of medical devices -<br>Part 5: Tests for in vitro cytotoxicity | Third edition 2009-<br>06-01 | 12/23/2016 |
| Standards No. | Standard Title | Version | Date |
| ISO 10993-10 | Biological evaluation of medical devices -<br>Part 10: Tests for irritation and skin<br>sensitization | Third Edition 2010-<br>08-01 | 07/26/2016 |

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# K202390

SHENZHEN KAIYAN MEDICAL CO LTD Sponsor: Aduro Light Beauty Mask

Subject Device: Document Name: 510(k) Summary

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## 7. Comparison to the predicate devices

| Elements<br>of<br>Comparison | Subject Device | Predicate<br>Device 1 | Predicate<br>Device 2<br>(Primary<br>device) | Predicate<br>Device 3 | Remark |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Company | SHENZHEN<br>KAIYAN<br>MEDICAL CO<br>LTD. | Galactic Beauty,<br>LLC | Beijing ADSS<br>Development<br>Co., Ltd. | ISMART<br>Marketing Svcs<br>Ltd | -- |
| Trade Name | Aduro Light<br>Beauty Mask | MMSphere | LED Therapy<br>Device | FaceLITE | -- |
| Classification<br>Name | Over-The-Counter<br>Powered Light<br>Based Laser For<br>Acne (OLP), Light<br>Based Over-The<br>Counter Wrinkle<br>Reduction (OHS) | Light Based Over<br>The Counter<br>Wrinkle<br>Reduction | Light Based<br>Over-The-<br>Counter<br>Powered Light<br>Based Laser For<br>Acne/Light<br>Based over the<br>Counter Wrinkle<br>Reduction | Light Based<br>Over the<br>Counter<br>Wrinkle<br>Reduction | -- |
| 510(k) Number | K202390 | K190443 | K192295 | K191629 | -- |
| Product Code | OLP, OHS | OLP, OHS | OLP, OHS | OHS | SE |
| Intended Use /<br>Indications for<br>Use | The Aduro Light<br>Beauty Mask<br>(Model: MK-660,<br>MK-66USBO, MK-<br>020) emits energy<br>in the red and<br>blue region of the<br>spectrum,<br>specifically<br>indicated to treat<br>full face wrinkles | MMSphere™<br>Light Therapy<br>Device emits<br>energy in the red,<br>blue and amber<br>regions of the<br>spectrum,<br>specifically<br>indicated to treat<br>wrinkles and/or<br>mild to moderate | The red light is<br>intended for the<br>treatment of<br>periorbital<br>wrinkles and the<br>blue light is<br>intended for the<br>treatment of the<br>mild to moderate<br>inflammatory<br>acne. The device | The faceLITE<br>LED mask is an<br>over the<br>counter device<br>that is intended<br>for the use in<br>the treatment of<br>full-face<br>wrinkles. | SE |

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Subject Device: Aduro Light Beauty Mask

Document Name: 510(k) Summary

Predicate Elements of Predicate Device 2 Predicate Subiect Device Remark Comparison Device 1 (Primary Device 3 device) acne. The and/or mild to is indicated for MMSphere™ is moderate acne. adults only. designed to be used for 20 minute treatments three to seven times per week. Red: Red: 630nm+/-Red: Red: 605nm 640nm±10nm 630nm±5nm 10nm Wavelengths SE Blue: 465nm Blue: Blue: NIR: 830nm+/-Amber: 625nm 465nm±10nm 415nm±5nm 10nm For model MK-660. MK-66USBO: 3.7Vdc 2600mAh 5.V DC 2.0 A Lithium battery Powered by Adapter for direct pluq-in charging only: Rechargeable Not publicly adapter: Input Power supply Input: 100-Lithium ion SE 100-240V AC, available polymer battery 240Vac: 50/60 Hz, 0.5A Output: 5Vdc, 2A. Max., Output 5.0V DC 2.0A For model MK-020: 3.7Vdc 2600mAh Lithium battery Irradiance LEDs LEDs LEDs LEDs SE source 10minutes/day, 3 3-5 minutes each 10 minutes each SE Treatment time 20 mins / day times per week treatment treatment See Note Red light: 80 Red: 2.45mW/cm² mW/cm²±10% Power Density 30mw/cm² 30mw/cm² total SE Blue: Blue light: 50 1.33mW/cm² mW/cm²±10% Location for Face Face Face SE Face Use Environment of ОТС ОТС ОТС ОТС SE Use IEC 60601-1, IEC 60601-1. IEC IEC 60601-1. IEC 60601-1. IEC 60601-1-2, 60601-1-2, IEC IEC 60601-1-2. IEC 60601-1-2, Safety and IEC 60601-1-6, 60601-1-6, IE C IEC 60601-1-6, IEC 60601-1-6, SE EMC IE C 60601-1-60601-1-11, IEC IEC 60601-1-11, IEC 60601-1-11, 11. IEC 60601-60601-2-57 IEC 60601-2-57 IEC 60601-2-57 2-57 ISO 10993-1, ISO ISO 10993-1. ISO 10993-1. Biocompatibility 10993-5, ISO ISO 10993-1 ISO 10993-5, ISO 10993-5, SE ISO 10993-10 10993-10 ISO 10993-10

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# K202390

SHENZHEN KAIYAN MEDICAL CO LTD Sponsor: Subject Device: Aduro Light Beauty Mask 510(k) Summary Document Name:

| Elements<br>of<br>Comparison | Subject Device | Predicate<br>Device 1 | Predicate<br>Device 2 | Predicate<br>Device 3<br>(Primary<br>device) | Remark |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------|
| Company | SHENZHEN<br>KAIYAN<br>MEDICAL CO<br>LTD. | Galactic Beauty,<br>LLC | Beijing ADSS<br>Development<br>Co., Ltd. | JOHNSON &<br>JOHNSON<br>CONSUMER<br>INC. | -- |
| Trade Name | Aduro Light<br>Beauty Mask | MMSphere | LED Therapy<br>Device | Neutrogena<br>Light Therapy<br>Acne Mask+ | -- |
| Classification<br>Name | Over-The-Counter<br>Powered Light<br>Based Laser For<br>Acne (OLP) | Light Based Over<br>The Counter<br>Wrinkle<br>Reduction | Light Based<br>Over-The-<br>Counter<br>Powered Light<br>Based Laser For<br>Acne/Light<br>Based over the<br>Counter Wrinkle<br>Reduction | Over the<br>Counter<br>powered Light<br>Based Laser for<br>Acne | -- |
| 510(k) Number | K202390 | K190443 | K192295 | K180847 | -- |
| Product Code | OLP | OHS, OLP | OHS, OLP | OLP | SE |
| Intended Use /<br>Indications for<br>Use | The Aduro Light<br>Beauty Mask<br>(Model: MK-<br>66USBA, MK-<br>02A) is intended<br>to emit light in the | MMSphereTM<br>Light Therapy<br>Device emits<br>energy in the red,<br>blue and amber<br>regions of the | The red light is<br>intended for the<br>treatment of<br>periorbital<br>wrinkles and the<br>blue light is | The Light<br>Therapy Acne<br>Mask + is<br>intended to<br>emit energy in<br>the red and | SE |
| Elements<br>of<br>Comparison | Subject Device | Predicate<br>Device 1 | Predicate<br>Device 2 | Predicate<br>Device 3<br>(Primary<br>device) | Remark |
| | blue region of the<br>spectrum,<br>specifically<br>indicated to treat<br>mild to moderate<br>acne on the face. | spectrum,<br>specifically<br>indicated to treat<br>wrinkles and/or<br>mild to moderate<br>acne. The<br>MMSphere™ is<br>designed to be<br>used for 20<br>minute<br>treatments three<br>to seven times<br>per week. | intended for the<br>treatment of the<br>mild to moderate<br>inflammatory<br>acne. The device<br>is indicated for<br>adults only. | blue region of<br>the spectrum,<br>specifically<br>indicated to<br>treat mild to<br>moderate acne<br>on the face. | |
| Wavelengths | Blue:<br>465nm±10nm | Red: 605nm<br>Blue: 465nm<br>Amber: 625nm | Red:<br>630nm±5nm<br>Blue:<br>415nm±5nm | Red: 620-<br>640nm<br>Blue: 425-<br>450nm | SE |
| Power supply | For model MK-<br>66USBA:<br>3.7Vdc 2600mAh<br>Lithium battery<br>Adapter for<br>charging only:<br>Input: 100-<br>240Vac;<br>Output: 5Vdc, 2A.<br>For model MK-<br>02A: 3.7Vdc<br>2600mAh Lithium<br>battery | Not publicly<br>available | 5.V DC 2.0 A<br>Powered by<br>direct plug-in<br>adapter: Input<br>100-240V AC,<br>50/60 Hz, 0.5A<br>Max., Output<br>5.0V DC 2.0A | Ni-MH Batteries | SE |
| Irradiance<br>source | LEDs | LEDs | LEDs | LEDs | SE |
| Treatment time | 10minutes/day, 3<br>times per week | 20 mins / day | 3-5 minutes each<br>time | 600 seconds | SE<br>See Note |
| Power Density | 30mw/cm² | Red:<br>2.45mW/cm²<br>Blue:<br>1.33mW/cm² | Red light: 80<br>mW/cm²±10%<br>Blue light: 50<br>mW/cm²±10% | 30mw/cm² total | SE |
| Location for<br>Use | Face | Face | Face | Face | SE |
| Environment of<br>Use | OTC | OTC | OTC | Home (OTC) | SE |
| Safety and<br>EMC | IEC 60601-1, IEC<br>60601-1-2, IEC<br>60601-1-6, IEC<br>60601-1-11, IEC<br>60601-2-57 | IEC 60601-1, IEC<br>60601-1-2, IEC<br>60601-1-6, IEC<br>60601-1-11, IEC<br>60601-2-57 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-6,<br>IEC 60601-1-11,<br>IEC 60601-2-57 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-6,<br>IEC 60601-1-<br>11, IEC 60601- | SE |
| Elements<br>of<br>Comparison | Subject Device | Predicate<br>Device 1 | Predicate<br>Device 2 | Predicate<br>Device 3<br>(Primary<br>device) | Remark |
| | | | | 2-57 | |
| Biocompatibility | ISO 10993-1, ISO<br>10993-5, ISO<br>10993-10 | ISO 10993-1 | ISO 10993-1,<br>ISO 10993-5,<br>ISO 10993-10 | ISO 10993-1 | SE |

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Subject Device: Aduro Light Beauty Mask

510(k) Summary Document Name:

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| Elements<br>of<br>Comparison | Subject Device | Predicate<br>Device 1 | Predicate<br>Device 2 | Predicate<br>Device 3<br>(Primary<br>device) | Remark |
|------------------------------|---------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------|
| Company | SHENZHEN<br>KAIYAN<br>MEDICAL CO<br>LTD. | Galactic Beauty,<br>LLC | Beijing ADSS<br>Development<br>Co., Ltd. | ISMART<br>Marketing Svcs<br>Ltd | -- |
| Trade Name | Aduro Light<br>Beauty Mask | MMSphere | LED Therapy<br>Device | FaceLITE | -- |
| Classification<br>Name | Light Based<br>Over-The<br>Counter Wrinkle<br>Reduction (OHS) | Light Based Over<br>The Counter<br>Wrinkle<br>Reduction | Light Based<br>Over-The-<br>Counter Powered<br>Light Based<br>Laser For<br>Acne/Light<br>Based over the<br>Counter Wrinkle<br>Reduction | Light Based<br>Over the<br>Counter<br>Wrinkle<br>Reduction | -- |
| 510(k) Number | K202390 | K190443 | K192295 | K191629 | -- |

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SHENZHEN KAIYAN MEDICAL CO LTD Sponsor:

Subject Device: Aduro Light Beauty Mask

510(k) Summary

Document Name:

Predicate Elements of Predicate Predicate Device 3 Subiect Device Remark Comparison Device 1 Device 2 (Primary device) OHS SE Product Code OHS OHS, OLP OHS, OLP MMSphere™ Light Therapy Device emits The red light is energy in the red, The Aduro Light blue and amber intended for the The faceLITE Beauty Mask regions of the treatment of LED mask is an (Model: MKspectrum, periorbital over the 66USBB, MKspecifically wrinkles and the counter device Intended Use / 02B) is an over indicated to treat blue light is that is intended Indications for the counter wrinkles and/or intended for the SE for the use in Use device that is mild to moderate treatment of the the treatment of intended for the acne. The mild to moderate full-face MMSphere™ is use in the inflammatory wrinkles. designed to be treatment of fullacne. The device face wrinkles. used for 20 is indicated for minute adults only. treatments three to seven times per week. Red: Red: 630nm+/-Red: 605nm 630nm±5nm Red: 10nm Wavelengths Blue: 465nm SE 640nm±10nm Blue: NIR: 830nm+/-Amber: 625nm 415nm±5nm 10nm For model MK-66USBB: 3.7Vdc 2600mAh Lithium battery 5.V DC 2.0 A Adapter for Powered by charging only: direct pluq-in Rechargeable Input: 100-Not publicly adapter: Input SE Power supply Lithium ion 100-240V AC, 240Vac: available polymer battery Output: 5Vdc, 2A. 50/60 Hz, 0.5A Max., Output For model MK-5.0V DC 2.0A 02B: 3.7Vdc 2600mAh Lithium battery Irradiance SE LEDs LEDs LEDs LEDs source 10minutes/day, 3 3-5 minutes each SE Treatment time 20 mins / day 600 seconds times per week See Note time Red: Red light: 80 2.45mW/cm² mW/cm²±10% Power Density 30mw/cm² 30mw/cm² total SE Blue: Blue light: 50 1.33mW/cm² mW/cm²±10% Location for Face SE Face Face Face Use

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| Sponsor: | SHENZHEN KAIYAN MEDICAL CO LTD |
|-----------------|--------------------------------|
| Subject Device: | Aduro Light Beauty Mask |
| Document Name: | 510(k) Summary |

| Elements<br>of<br>Comparison | Subject Device | Predicate<br>Device 1 | Predicate<br>Device 2 | Predicate<br>Device 3<br>(Primary<br>device) | Remark |
|------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------|
| Environment of<br>Use | OTC | OTC | OTC | OTC | SE |
| Safety and<br>EMC | IEC 60601-1, IEC<br>60601-1-2, IEC<br>60601-1-6, IE C<br>60601-1-11, IEC<br>60601-2-57 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-6,<br>IEC 60601-1-11,<br>IEC 60601-2-57 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-6,<br>IEC 60601-1-11,<br>IEC 60601-2-57 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-6,<br>IE C 60601-1-<br>11, IEC 60601-<br>2-57 | SE |
| Biocompatibility | ISO 10993-1, ISO<br>10993-5, ISO<br>10993-10 | ISO 10993-1 | ISO 10993-1,<br>ISO 10993-5,<br>ISO 10993-10 | ISO 10993-1,<br>ISO 10993-5,<br>ISO 10993-10 | SE |

Note: The treatment time of the subject device is different than the predicate devices. However, it is considered to be within an acceptable range and does not raise concerns regarding safety and effectiveness, and new clinical studies were not considered to be necessary for the subject device.

### 8. Conclusion:

After an analysis of intended use, performance, safety, and technological characteristics of the subject device, the sponsor believes that it has demonstrated that the subject device can be operated safely and effectively for the proposed indications for use. When compared to the predicate devices, the subject device does not raise new issues of safety or effectiveness. Therefore, the sponsor believes that the subject Aduro Light Beauty Mask models listed above are substantially equivalent to the predicate devices.

Date that summary was prepared: July 8, 2021