(327 days)
No
The device description focuses solely on the light emission technology and a simple timer function. There is no mention of any data processing, learning, or adaptive capabilities that would indicate the presence of AI/ML.
Yes.
The device is specifically indicated to treat full face wrinkles and/or mild to moderate acne, which are therapeutic claims.
No
The device is intended for treatment (e.g., treating wrinkles and acne) by emitting light, not for diagnosing medical conditions.
No
The device description clearly states it is a "facemask-shaped device" that "makes use of specific light spectral characteristics and directly applies light onto the face skin surface" using "66 LEDs". This indicates a physical hardware component that emits light, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Aduro Light Beauty Mask applies light directly to the skin surface for therapeutic purposes (treating wrinkles and acne). It does not analyze any biological samples.
- Intended Use: The intended use clearly states treatment of wrinkles and acne, not diagnosis or analysis of biological specimens.
- Device Description: The description focuses on the light emission and application to the face, not on any form of sample analysis.
Therefore, the Aduro Light Beauty Mask falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OHS, OLP, ILY
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed based on the following standards:
ES 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11 Medical electrical equipment - Part 1-11: 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 light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 62366-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
The non-clinical testing demonstrates that the subject device can be operated safely and effectively for the proposed indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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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3
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
4
| Predicate
device | Predicate device
1 | Predicate device 2 | Predicate
device 3 |
|--------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Sponsor | Galactic Beauty,
LLC | Beijing ADSS Development
Co., Ltd. | ISMART
Marketing Svcs
Ltd |
| Device Name
and Model | MMSphere | LED Therapy Device | FaceLITE |
| 510(k) Number | K190443 | K192295 | K191629 |
| Classification
Name | Light Based Over-
The-Counter Acne
Treatment / Light
Based Over the
Counter Wrinkle
Reduction | Light Based Over-The-
Counter Acne Treatment /
Light Based over the Counter
Wrinkle Reduction | Light Based
Over-The-
Counter
Wrinkle
Reduction |
| Review Panel | General & Plastic
Surgery | General & Plastic Surgery | General &
Plastic Surgery |
| Product Code | OLP, OHS | OLP, OHS | OHS |
| Regulation
Number | 878.4810 | 878.4810 | 878.4810 |
| Regulation
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.
5
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 and | |||
| essential performance | 2005/(R)2012 and | ||
| A1:2012 | 07/09/2014 | ||
| Standards No. | Standard Title | Version | Date |
| IEC 60601-1-11 | Medical electrical equipment - Part 1-11: | ||
| General requirements for basic safety and | |||
| essential performance - Collateral | |||
| Standard: Requirements for medical | |||
| electrical equipment and medical electrical | |||
| systems used in the home healthcare | |||
| environment | Edition 2.0 2015-01 | 06/27/2016 | |
| IEC 60601-2-57 | Medical Electrical Equipment - Part 2-57: | ||
| Particular requirements for the basic safety | |||
| and essential performance of non-laser | |||
| light source equipment intended for | |||
| therapeutic, diagnostic, monitoring and | |||
| cosmetic/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 and | |||
| essential performance - Collateral | |||
| Standard: Electromagnetic disturbances - | |||
| Requirements and tests | Edition 4.0 2014-02 | 09/17/2018 | |
| IEC 62366-2 | Secondary cells and batteries containing | ||
| alkaline or other non-acid electrolytes - | |||
| Safety requirements for portable sealed | |||
| secondary cells, and for batteries made | |||
| from 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 skin
sensitization | Third Edition 2010-
08-01 | 07/26/2016 |
6
K202390
SHENZHEN KAIYAN MEDICAL CO LTD Sponsor: Aduro Light Beauty Mask
Subject Device: Document Name: 510(k) Summary
7
7. Comparison to the predicate devices
| Elements
of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2
(Primary
device) | Predicate
Device 3 | Remark |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Company | SHENZHEN
KAIYAN
MEDICAL CO
LTD. | Galactic Beauty,
LLC | Beijing ADSS
Development
Co., Ltd. | ISMART
Marketing Svcs
Ltd | -- |
| Trade Name | Aduro Light
Beauty Mask | MMSphere | LED Therapy
Device | FaceLITE | -- |
| Classification
Name | Over-The-Counter
Powered Light
Based Laser For
Acne (OLP), Light
Based Over-The
Counter Wrinkle
Reduction (OHS) | Light Based Over
The Counter
Wrinkle
Reduction | Light Based
Over-The-
Counter
Powered Light
Based Laser For
Acne/Light
Based over the
Counter Wrinkle
Reduction | Light Based
Over the
Counter
Wrinkle
Reduction | -- |
| 510(k) Number | K202390 | K190443 | K192295 | K191629 | -- |
| Product Code | OLP, OHS | OLP, OHS | OLP, OHS | OHS | SE |
| Intended Use /
Indications for
Use | 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 | MMSphere™
Light Therapy
Device emits
energy in the red,
blue and amber
regions of the
spectrum,
specifically
indicated to treat
wrinkles and/or
mild to moderate | The red light is
intended for the
treatment of
periorbital
wrinkles and the
blue light is
intended for the
treatment of the
mild to moderate
inflammatory
acne. The device | The faceLITE
LED mask is an
over the
counter device
that is intended
for the use in
the treatment of
full-face
wrinkles. | SE |
8
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
9
K202390
SHENZHEN KAIYAN MEDICAL CO LTD Sponsor: Subject Device: Aduro Light Beauty Mask 510(k) Summary Document Name:
| Elements
of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3
(Primary
device) | Remark |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------|
| Company | SHENZHEN
KAIYAN
MEDICAL CO
LTD. | Galactic Beauty,
LLC | Beijing ADSS
Development
Co., Ltd. | JOHNSON &
JOHNSON
CONSUMER
INC. | -- |
| Trade Name | Aduro Light
Beauty Mask | MMSphere | LED Therapy
Device | Neutrogena
Light Therapy
Acne Mask+ | -- |
| Classification
Name | Over-The-Counter
Powered Light
Based Laser For
Acne (OLP) | Light Based Over
The Counter
Wrinkle
Reduction | Light Based
Over-The-
Counter
Powered Light
Based Laser For
Acne/Light
Based over the
Counter Wrinkle
Reduction | Over the
Counter
powered Light
Based Laser for
Acne | -- |
| 510(k) Number | K202390 | K190443 | K192295 | K180847 | -- |
| Product Code | OLP | OHS, OLP | OHS, OLP | OLP | SE |
| Intended Use /
Indications for
Use | The Aduro Light
Beauty Mask
(Model: MK-
66USBA, MK-
02A) is intended
to emit light in the | MMSphereTM
Light Therapy
Device emits
energy in the red,
blue and amber
regions of the | The red light is
intended for the
treatment of
periorbital
wrinkles and the
blue light is | The Light
Therapy Acne
Mask + is
intended to
emit energy in
the red and | SE |
| Elements
of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3
(Primary
device) | Remark |
| | blue region of the
spectrum,
specifically
indicated to treat
mild to moderate
acne on the face. | spectrum,
specifically
indicated to treat
wrinkles and/or
mild to moderate
acne. The
MMSphere™ is
designed to be
used for 20
minute
treatments three
to seven times
per week. | intended for the
treatment of the
mild to moderate
inflammatory
acne. The device
is indicated for
adults only. | blue region of
the spectrum,
specifically
indicated to
treat mild to
moderate acne
on the face. | |
| Wavelengths | Blue:
465nm±10nm | Red: 605nm
Blue: 465nm
Amber: 625nm | Red:
630nm±5nm
Blue:
415nm±5nm | Red: 620-
640nm
Blue: 425-
450nm | SE |
| Power supply | For model MK-
66USBA:
3.7Vdc 2600mAh
Lithium battery
Adapter for
charging only:
Input: 100-
240Vac;
Output: 5Vdc, 2A.
For model MK-
02A: 3.7Vdc
2600mAh Lithium
battery | Not publicly
available | 5.V DC 2.0 A
Powered by
direct plug-in
adapter: Input
100-240V AC,
50/60 Hz, 0.5A
Max., Output
5.0V DC 2.0A | Ni-MH Batteries | SE |
| Irradiance
source | LEDs | LEDs | LEDs | LEDs | SE |
| Treatment time | 10minutes/day, 3
times per week | 20 mins / day | 3-5 minutes each
time | 600 seconds | SE
See Note |
| Power Density | 30mw/cm² | Red:
2.45mW/cm²
Blue:
1.33mW/cm² | Red light: 80
mW/cm²±10%
Blue light: 50
mW/cm²±10% | 30mw/cm² total | SE |
| Location for
Use | Face | Face | Face | Face | SE |
| Environment of
Use | OTC | OTC | OTC | Home (OTC) | SE |
| Safety and
EMC | 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,
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 |
| Elements
of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3
(Primary
device) | Remark |
| | | | | 2-57 | |
| Biocompatibility | ISO 10993-1, ISO
10993-5, ISO
10993-10 | 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
| Elements
of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3
(Primary
device) | Remark |
|------------------------------|---------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------|
| Company | SHENZHEN
KAIYAN
MEDICAL CO
LTD. | Galactic Beauty,
LLC | Beijing ADSS
Development
Co., Ltd. | ISMART
Marketing Svcs
Ltd | -- |
| Trade Name | Aduro Light
Beauty Mask | MMSphere | LED Therapy
Device | FaceLITE | -- |
| Classification
Name | Light Based
Over-The
Counter Wrinkle
Reduction (OHS) | Light Based Over
The Counter
Wrinkle
Reduction | Light Based
Over-The-
Counter Powered
Light Based
Laser For
Acne/Light
Based over the
Counter Wrinkle
Reduction | Light Based
Over the
Counter
Wrinkle
Reduction | -- |
| 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
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| Sponsor: | SHENZHEN KAIYAN MEDICAL CO LTD |
|---|---|
| Subject Device: | Aduro Light Beauty Mask |
| Document Name: | 510(k) Summary |
| Elements
of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3
(Primary
device) | Remark |
|------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------|
| Environment of
Use | OTC | OTC | OTC | OTC | SE |
| Safety and
EMC | IEC 60601-1, IEC
60601-1-2, IEC
60601-1-6, IE C
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,
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, ISO
10993-5, ISO
10993-10 | 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