(327 days)
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.
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.
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.
The provided text describes a 510(k) summary for the Aduro Light Beauty Mask, which aims to demonstrate substantial equivalence to previously cleared predicate devices. This type of submission relies on comparisons to existing devices rather than new clinical effectiveness studies for the product itself. Therefore, the data provided is primarily about comparative equivalence for safety and basic performance metrics, rather than a full-fledged clinical study proving specific acceptance criteria for AI algorithm performance or human-in-the-loop improvements.
Based on the document, here's a breakdown of the requested information, with an emphasis on what is available and what is not in this type of regulatory submission:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria are implicitly defined by the characteristics of the predicate devices. The "reported device performance" is the comparison showing that the subject device's specifications are within an acceptable range or are substantially equivalent to the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implied by Predicates) | Reported Device Performance (Aduro Light Beauty Mask) |
|---|---|---|
| For MK-660, MK-66USBO, MK-020 (Red and Blue Light - Wrinkles & Acne) | MMSphere (Predicate 1): Emits energy in red, blue, and amber regions for wrinkles and/or mild to moderate acne. Treatment time 20 mins/day, 3-7 times/week. Wavelengths: Red: 605nm, Blue: 465nm, Amber: 625nm. Power Density: Red: 2.45mW/cm², Blue: 1.33mW/cm². LED Therapy Device (Predicate 2 - Primary): Red light for periorbital wrinkles, blue light for mild to moderate inflammatory acne. Treatment time 3-5 minutes each treatment. Wavelengths: Red: 630nm±5nm, Blue: 415nm±5nm. Power Density: Red: 80mW/cm²±10%, Blue: 50mW/cm²±10%. FaceLITE (Predicate 3): For full-face wrinkles. Wavelengths: Red: 630nm+/-10nm. Treatment time 600 seconds (10 minutes). | Emits energy in red and blue regions, specifically indicated to treat full face wrinkles and/or mild to moderate acne. Wavelengths: Red: 640nm±10nm, Blue: 465nm±10nm. Power Density: 30mW/cm² (total). Treatment Time: 10 minutes/day, 3 times per week. Power Supply: 3.7Vdc 2600mAh Lithium battery, Adapter for charging only: Input 100-240Vac, Output 5Vdc, 2A. LEDs as Irradiance Source. Face: Location for Use. OTC: Environment of Use. |
| For MK-66USBA, MK-02A (Blue Light - Acne) | MMSphere (Predicate 1): (as above, includes blue light for acne). LED Therapy Device (Predicate 2 - Primary): (as above, includes blue light for acne). Neutrogena Light Therapy Acne Mask+ (Predicate 3): Emits energy in red and blue regions for mild to moderate acne. Treatment time 600 seconds (10 minutes). Wavelengths: Red: 620-640nm, Blue: 425-450nm. | Intended to emit light in the blue region, specifically indicated to treat mild to moderate acne on the face. Wavelength: Blue: 465nm±10nm. Power Density: 30mW/cm². Treatment Time: 10 minutes/day, 3 times per week. Power Supply: 3.7Vdc 2600mAh Lithium battery, Adapter for charging only: Input 100-240Vac, Output 5Vdc, 2A. LEDs as Irradiance Source. Face: Location for Use. OTC: Environment of Use. |
| For MK-66USBB, MK-02B (Red Light - Wrinkles) | MMSphere (Predicate 1): (as above, includes red light for wrinkles). LED Therapy Device (Predicate 2 - Primary): (as above, includes red light for wrinkles). FaceLITE (Predicate 3): For full-face wrinkles. Wavelengths: Red: 630nm+/-10nm. Treatment time 600 seconds (10 minutes). | Intended for the treatment of full-face wrinkles. Wavelength: Red: 640nm±10nm. Power Density: 30mW/cm². Treatment Time: 10 minutes/day, 3 times per week. Power Supply: 3.7Vdc 2600mAh Lithium battery, Adapter for charging only: Input 100-240Vac, Output 5Vdc, 2A. LEDs as Irradiance Source. Face: Location for Use. OTC: Environment of Use. |
| Safety and EMF Standards | Compliance with relevant IEC and ISO standards for medical electrical equipment, electromagnetic disturbances, home healthcare, light source equipment, and biocompatibility. Generally IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, ISO 10993-5, ISO 10993-10. | The device has been evaluated for safety and performance through testing against: ES 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-1-2, IEC 62366-2 (Lithium systems), ISO 10993-5, ISO 10993-10. This indicates compliance with the safety and EMC standards found in the predicate devices. |
| Biocompatibility | Compliance with ISO 10993 series (e.g., ISO 10993-1, ISO 10993-5, ISO 10993-10). | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10. |
Note: The document explicitly states: "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." This indicates that while not identical, the differing treatment time was deemed acceptably similar.
Regarding the study proving the device meets acceptance criteria (Note: This is NOT an AI/algorithm study as per the typical questions, but rather a regulatory premarket submission for an LED light therapy device):
This document is a 510(k) Summary, which is designed to demonstrate substantial equivalence to a previously cleared device, rather than proving de novo effectiveness through a full clinical trial with "acceptance criteria" in the sense of an algorithm's performance metrics (e.g., sensitivity, specificity). The "study" mentioned here refers to the non-clinical testing and comparison to predicates.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of human clinical trial test sets. The "test set" here refers to the physical device undergoing non-clinical bench testing to ensure it meets safety and performance standards (e.g., wavelength accuracy, power output, electrical safety, biocompatibility). The document does not specify the number of devices tested.
- Data Provenance: The document explicitly mentions "Non-clinical Testing" being performed. It does not provide details on the country of origin for this testing or whether it was retrospective or prospective, but these would typically be lab-based, prospective tests on manufactured units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to this type of device submission. Ground truth, in the context of AI, usually refers to expert-labeled data (e.g., radiologists labeling medical images). For an LED light therapy device, "ground truth" relates to measurable physical parameters and safety standards, verified by engineering and quality control processes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 (two experts agree, third resolves discrepancy) are used for establishing ground truth in clinical data for diagnostic or AI-assisted devices. This document describes the substantial equivalence of a light therapy device based on physical characteristics and safety standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was explicitly NOT done. This type of study demonstrates the clinical utility of a device, often for diagnostic tools or AI. The document states in the "Note" section (Page 13): "new clinical studies were not considered to be necessary for the subject device." This strongly indicates that the approval was based on demonstrating equivalence to predicates through technical and safety data, not new clinical effectiveness data. Therefore, there is no effect size related to human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical light therapy mask, not an AI algorithm. There is no standalone algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is based on established engineering and safety standards and specifications (e.g., specified wavelengths, power densities, electrical safety standards like IEC 60601 series, and biocompatibility standards like ISO 10993 series). Device performance is measured against these technical specifications, not against clinical outcomes or expert consensus on clinical findings in patient data.
8. The sample size for the training set:
- Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI algorithm, there is no training set or ground truth establishment method for it.
In summary: The provided document is a 510(k) summary for a physical medical device (LED light therapy mask), not an AI-powered diagnostic or therapeutic algorithm. Therefore, many of the questions related to AI algorithm acceptance criteria, test sets, ground truth establishment, and multi-reader studies are not applicable to this submission. The "study" proving acceptance criteria is the collection of non-clinical bench testing data and a comprehensive comparison of the device's technical specifications and safety profile to those of legally marketed predicate devices, demonstrating "substantial equivalence."
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 0755-82129361 Fax: 0755-25024651 E-mail: alaindijkstra@kaiyanmedical.com
Application Correspondent:
Contact Person: Alain Dijkstra SHENZHEN KAIYAN MEDICAL CO LTD. Address: 40A Fuxin Road, Fuyong Subdistrict, BaoAn District, Shenzhen Guangdong, China Tel: 0755-82129361 Email: requlation@kaiyanmedical.com
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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| Predicatedevice | Predicate device1 | Predicate device 2 | Predicatedevice 3 |
|---|---|---|---|
| Sponsor | Galactic Beauty,LLC | Beijing ADSS DevelopmentCo., Ltd. | ISMARTMarketing SvcsLtd |
| Device Nameand Model | MMSphere | LED Therapy Device | FaceLITE |
| 510(k) Number | K190443 | K192295 | K191629 |
| ClassificationName | Light Based Over-The-Counter AcneTreatment / LightBased Over theCounter WrinkleReduction | Light Based Over-The-Counter Acne Treatment /Light Based over the CounterWrinkle Reduction | Light BasedOver-The-CounterWrinkleReduction |
| Review Panel | General & PlasticSurgery | General & Plastic Surgery | General &Plastic Surgery |
| Product Code | OLP, OHS | OLP, OHS | OHS |
| RegulationNumber | 878.4810 | 878.4810 | 878.4810 |
| RegulationClass | 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:General requirements for basic safety andessential performance | 2005/(R)2012 andA1:2012 | 07/09/2014 |
| Standards No. | Standard Title | Version | Date |
| IEC 60601-1-11 | Medical electrical equipment - Part 1-11:General requirements for basic safety andessential performance - CollateralStandard: Requirements for medicalelectrical equipment and medical electricalsystems used in the home healthcareenvironment | Edition 2.0 2015-01 | 06/27/2016 |
| IEC 60601-2-57 | Medical Electrical Equipment - Part 2-57:Particular requirements for the basic safetyand essential performance of non-laserlight source equipment intended fortherapeutic, diagnostic, monitoring andcosmetic/aesthetic use | Edition 1.0 2011-01 | 03/16/2012 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - CollateralStandard: Electromagnetic disturbances -Requirements and tests | Edition 4.0 2014-02 | 09/17/2018 |
| IEC 62366-2 | Secondary cells and batteries containingalkaline or other non-acid electrolytes -Safety requirements for portable sealedsecondary cells, and for batteries madefrom them, for use in portable applications- Part 2: Lithium systems | Edition 1.0 2017-02 | 12/23/2019 |
| ISO 10993-5 | Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity | Third edition 2009-06-01 | 12/23/2016 |
| Standards No. | Standard Title | Version | Date |
| ISO 10993-10 | Biological evaluation of medical devices -Part 10: Tests for irritation and skinsensitization | Third Edition 2010-08-01 | 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
| ElementsofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2(Primarydevice) | PredicateDevice 3 | Remark |
|---|---|---|---|---|---|
| Company | SHENZHENKAIYANMEDICAL COLTD. | Galactic Beauty,LLC | Beijing ADSSDevelopmentCo., Ltd. | ISMARTMarketing SvcsLtd | -- |
| Trade Name | Aduro LightBeauty Mask | MMSphere | LED TherapyDevice | FaceLITE | -- |
| ClassificationName | Over-The-CounterPowered LightBased Laser ForAcne (OLP), LightBased Over-TheCounter WrinkleReduction (OHS) | Light Based OverThe CounterWrinkleReduction | Light BasedOver-The-CounterPowered LightBased Laser ForAcne/LightBased over theCounter WrinkleReduction | Light BasedOver theCounterWrinkleReduction | -- |
| 510(k) Number | K202390 | K190443 | K192295 | K191629 | -- |
| Product Code | OLP, OHS | OLP, OHS | OLP, OHS | OHS | SE |
| Intended Use /Indications forUse | The Aduro LightBeauty Mask(Model: MK-660,MK-66USBO, MK-020) emits energyin the red andblue region of thespectrum,specificallyindicated to treatfull face wrinkles | MMSphere™Light TherapyDevice emitsenergy in the red,blue and amberregions of thespectrum,specificallyindicated to treatwrinkles and/ormild to moderate | The red light isintended for thetreatment ofperiorbitalwrinkles and theblue light isintended for thetreatment of themild to moderateinflammatoryacne. The device | The faceLITELED mask is anover thecounter devicethat is intendedfor the use inthe treatment offull-facewrinkles. | 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:
| ElementsofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3(Primarydevice) | Remark |
|---|---|---|---|---|---|
| Company | SHENZHENKAIYANMEDICAL COLTD. | Galactic Beauty,LLC | Beijing ADSSDevelopmentCo., Ltd. | JOHNSON &JOHNSONCONSUMERINC. | -- |
| Trade Name | Aduro LightBeauty Mask | MMSphere | LED TherapyDevice | NeutrogenaLight TherapyAcne Mask+ | -- |
| ClassificationName | Over-The-CounterPowered LightBased Laser ForAcne (OLP) | Light Based OverThe CounterWrinkleReduction | Light BasedOver-The-CounterPowered LightBased Laser ForAcne/LightBased over theCounter WrinkleReduction | Over theCounterpowered LightBased Laser forAcne | -- |
| 510(k) Number | K202390 | K190443 | K192295 | K180847 | -- |
| Product Code | OLP | OHS, OLP | OHS, OLP | OLP | SE |
| Intended Use /Indications forUse | The Aduro LightBeauty Mask(Model: MK-66USBA, MK-02A) is intendedto emit light in the | MMSphereTMLight TherapyDevice emitsenergy in the red,blue and amberregions of the | The red light isintended for thetreatment ofperiorbitalwrinkles and theblue light is | The LightTherapy AcneMask + isintended toemit energy inthe red and | SE |
| ElementsofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3(Primarydevice) | Remark |
| blue region of thespectrum,specificallyindicated to treatmild to moderateacne on the face. | spectrum,specificallyindicated to treatwrinkles and/ormild to moderateacne. TheMMSphere™ isdesigned to beused for 20minutetreatments threeto seven timesper week. | intended for thetreatment of themild to moderateinflammatoryacne. The deviceis indicated foradults only. | blue region ofthe spectrum,specificallyindicated totreat mild tomoderate acneon the face. | ||
| Wavelengths | Blue:465nm±10nm | Red: 605nmBlue: 465nmAmber: 625nm | Red:630nm±5nmBlue:415nm±5nm | Red: 620-640nmBlue: 425-450nm | SE |
| Power supply | For model MK-66USBA:3.7Vdc 2600mAhLithium batteryAdapter forcharging only:Input: 100-240Vac;Output: 5Vdc, 2A.For model MK-02A: 3.7Vdc2600mAh Lithiumbattery | Not publiclyavailable | 5.V DC 2.0 APowered bydirect plug-inadapter: Input100-240V AC,50/60 Hz, 0.5AMax., Output5.0V DC 2.0A | Ni-MH Batteries | SE |
| Irradiancesource | LEDs | LEDs | LEDs | LEDs | SE |
| Treatment time | 10minutes/day, 3times per week | 20 mins / day | 3-5 minutes eachtime | 600 seconds | SESee Note |
| Power Density | 30mw/cm² | Red:2.45mW/cm²Blue:1.33mW/cm² | Red light: 80mW/cm²±10%Blue light: 50mW/cm²±10% | 30mw/cm² total | SE |
| Location forUse | Face | Face | Face | Face | SE |
| Environment ofUse | OTC | OTC | OTC | Home (OTC) | SE |
| Safety andEMC | IEC 60601-1, IEC60601-1-2, IEC60601-1-6, IEC60601-1-11, IEC60601-2-57 | IEC 60601-1, IEC60601-1-2, IEC60601-1-6, IEC60601-1-11, IEC60601-2-57 | IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6,IEC 60601-1-11,IEC 60601-2-57 | IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6,IEC 60601-1-11, IEC 60601- | SE |
| ElementsofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3(Primarydevice) | Remark |
| 2-57 | |||||
| Biocompatibility | ISO 10993-1, ISO10993-5, ISO10993-10 | ISO 10993-1 | ISO 10993-1,ISO 10993-5,ISO 10993-10 | ISO 10993-1 | SE |
{10}------------------------------------------------
Subject Device: Aduro Light Beauty Mask
510(k) Summary Document Name:
{11}------------------------------------------------
| ElementsofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3(Primarydevice) | Remark |
|---|---|---|---|---|---|
| Company | SHENZHENKAIYANMEDICAL COLTD. | Galactic Beauty,LLC | Beijing ADSSDevelopmentCo., Ltd. | ISMARTMarketing SvcsLtd | -- |
| Trade Name | Aduro LightBeauty Mask | MMSphere | LED TherapyDevice | FaceLITE | -- |
| ClassificationName | Light BasedOver-TheCounter WrinkleReduction (OHS) | Light Based OverThe CounterWrinkleReduction | Light BasedOver-The-Counter PoweredLight BasedLaser ForAcne/LightBased over theCounter WrinkleReduction | Light BasedOver theCounterWrinkleReduction | -- |
| 510(k) Number | K202390 | K190443 | K192295 | K191629 | -- |
{12}------------------------------------------------
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
{13}------------------------------------------------
| Sponsor: | SHENZHEN KAIYAN MEDICAL CO LTD |
|---|---|
| Subject Device: | Aduro Light Beauty Mask |
| Document Name: | 510(k) Summary |
| ElementsofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3(Primarydevice) | Remark |
|---|---|---|---|---|---|
| Environment ofUse | OTC | OTC | OTC | OTC | SE |
| Safety andEMC | IEC 60601-1, IEC60601-1-2, IEC60601-1-6, IE C60601-1-11, IEC60601-2-57 | IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6,IEC 60601-1-11,IEC 60601-2-57 | IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6,IEC 60601-1-11,IEC 60601-2-57 | IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6,IE C 60601-1-11, IEC 60601-2-57 | SE |
| Biocompatibility | ISO 10993-1, ISO10993-5, ISO10993-10 | ISO 10993-1 | ISO 10993-1,ISO 10993-5,ISO 10993-10 | ISO 10993-1,ISO 10993-5,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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.