(90 days)
No
The description focuses on the hardware (LEDs, mask form, controller) and its basic functions (on/off, mode switching, timer). There is no mention of data processing, learning, or adaptive behavior that would indicate AI/ML. The software validation mentioned is standard for medical devices and doesn't imply AI/ML.
Yes.
The device is intended for the treatment of wrinkles and mild to moderate acne, which are therapeutic indications, and it operates by emitting LED light to achieve this effect.
No
The device is intended for the treatment of wrinkles and mild to moderate acne using LED light, which is a therapeutic function, not a diagnostic one. It irradiates light onto the face for treatment purposes, and there is no mention of it analyzing or identifying medical conditions.
No
The device description clearly outlines physical hardware components including an LED mask, a controller, and a power adapter, and the performance studies include testing of these hardware components against various electrical and safety standards.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the treatment of wrinkles and mild to moderate acne using LED light. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details how the LED light is applied to the face for therapeutic effect. There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) which is characteristic of IVDs.
- Lack of IVD-related information: The document does not mention any of the typical elements associated with IVDs, such as:
- Analyzing samples
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the device's function is to deliver light therapy directly to the skin for treatment purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP
Device Description
The Beauty LED Mask adopts light emitting diodes (LED) in the red (637nm ± 5nm) + infrared (854nm ± 5nm) and blue (465 ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The Beauty LED Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). Power adapter is provided to charge the battery contained in the controller. To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, Beauty LED Mask has incorporated protective eye-shield which blocks light energy from LEDs.
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
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 testings have been conducted to verify that the Beauty LED Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:
- A ANSI AAMI ES 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- A 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
- A 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
- A 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 62471, Photobiological safety of lamps and lamp systems A
- A IEC 62133-2, 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
The device has been tested for biocompatibility, it complies with the following standards. - A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted: - Software verification and validation test according to the requirements of the FDA "Guidance A for Pre Market Submissions and for Software Contained in Medical Devices"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 19, 2022
Hunan Guangye Biotechnology Co., Ltd. % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518052 China
Re: K221151
Trade/Device Name: Beauty LED Mask, Model: KFB265 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OHS, OLP Dated: April 8, 2022 Received: April 20, 2022
Dear Tracy Che:
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 postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221151
Device Name Beauty LED Mask, Model: KFB265
Indications for Use (Describe)
The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
| 510(k) owner's name: | Hunan Guangye Biotechnology Co., Ltd. |
|---|---|
| Address: | Room 701, Jinhong Park Incubation Building, No.229, Tongzipo |
| West Road, High-tech Development Zone, Changsha City | |
| Contact person: | Eileen Li |
| Phone number: | +86-0755-89373426 |
| Fax number: | +86-0755-89373426 |
| Email: | 412904775@qq.com |
| Date of summary prepared: | 2022-7-15 |
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name/model: | Beauty LED Mask/Model: KFB265 |
|---|---|
| Common name: | Over-The-Counter Powered Light Based Laser For Acne; |
| Light Based Over The Counter Wrinkle Reduction | |
| Regulation number: | 21 CFR 878.4810 |
| Product code: | OHS, OLP |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |
(4) Predicate and reference device
Predicate device >
| Sponsor | LG Electronics, Inc. |
|---|---|
| Device Name and Model | LG PRA.L DERMA LED MASK |
| 510(k) Number | K183671 |
| Product Code | OHS |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | II |
| Reference device | |
| Sponsor | Galactic Beauty, LLC |
| Device Name and Model | MMSphere™ |
4
| 510(k) Number | K190443 |
|---|---|
| Product Code | OHS, OLP |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | II |
(5) Description/ Design of device:
The Beauty LED Mask adopts light emitting diodes (LED) in the red (637nm ± 5nm) + infrared (854nm ± 5nm) and blue (465 ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The Beauty LED Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). Power adapter is provided to charge the battery contained in the controller. To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, Beauty LED Mask has incorporated protective eye-shield which blocks light energy from LEDs.
(6) Indications for use:
The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
| Component
| name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| Beauty LED | |||
| Mask | ABS, Silicone | Surface-contacting | |
| device: Intact skin | Less than 24 hours |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".
(8) Technological characteristics and substantial equivalence:
| Item | Subject device | Predicate device | Reference device | Remark |
|---|---|---|---|---|
| Trade name | Beauty LED Mask/ | |||
| Model: KFB265 | LG PRA.L DERMA | |||
| LED MASK | MMSphere™ | / | ||
| 510 (k) number | Applying | K183671 | K190443 | / |
| Manufacturer | Hunan Guangye | |||
| Biotechnology Co., Ltd. | LG Electronics, Inc. | Galactic Beauty, LLC | / | |
| Regulation | ||||
| number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Classification | ||||
| name | Light Based Over The | |||
| Counter Wrinkle and | Light Based Over The | |||
| Counter Wrinkle | OTC Powered Light for | |||
| Wrinkle Reduction and | Same |
5
| Acne Reduction | Reduction | Acne | ||
|---|---|---|---|---|
| Product code | OHS, OLP | OHS | OHS, OLP | Same |
| Class | II | II | II | Same |
| Indications for use/ | ||||
| Intended use | The device is intended | |||
| to use LED light for the | ||||
| treatment of wrinkles | ||||
| and mild to moderate | ||||
| acne. | The LG PRA.L | |||
| DERMA LED MASK | ||||
| is an over the counter | ||||
| device that is intended | ||||
| for the use in the | ||||
| treatment of full face | ||||
| wrinkles. | MMSphereTM 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 acne. | ||||
| The MMSphereTM is | ||||
| designed to be used for | ||||
| 20 minute treatments | ||||
| three to seven times per | ||||
| week. | Similar | |||
| Location for use | Face | Face | Face | Same |
| OTC or prescription | OTC | OTC | OTC | Same |
| Power supply | Input: 100 -240 V ~ 50 / | |||
| 60 Hz | ||||
| Output: 5V 1A | Input: AC 100V ~/ | |||
| 240V | ||||
| Frequency: 50Hz/ | ||||
| 60Hz | ||||
| Output: 5V 2A | Different | |||
| Note 1 | ||||
| Light source | Light Emitting Diodes | |||
| (LED) | Light Emitting Diodes | |||
| (LED) | Light Emitting Diodes | |||
| (LED) | Same | |||
| Wavelength | Red (637nm±5nm) and | |||
| IR (854nm±5nm); | ||||
| Blue (465±5nm) | RED (637nm) and IR | |||
| (854nm) | 465nm | |||
| 605nm | ||||
| 625nm | Similar | |||
| LED power | Red+IR: 25.5mW/cm² | |||
| Blue: 1.36mW/cm² | Red+IR: 25mW/cm² | Red: 2.45mW/cm² | ||
| Blue: 1.33mW/cm² | Similar | |||
| Treatment time | 10min each time | 9 minutes daily | ||
| 5 days per week for 8 | ||||
| weeks | 20mins/day, | |||
| 120 days | Similar | |||
| Mask design | Yes | Yes | Handheld or placed on | |
| a countertop | Same | |||
| Dimensions | ||||
| (mm) | LED Mask: | |||
| Approximately 183 mm | ||||
| x 238 mm x 98 mm | ||||
| Controller: 100mm x 50 | ||||
| mm x 21.5 mm | LED Mask: 180 x/ | |||
| 214.5 x 92.4 | ||||
| Controller: 41 x 31 x | ||||
| 103 | Different | |||
| Note 2 |
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| Weight | 245g | LED Mask: 207 g
Controller: 82 g
Adaptor: 75 g
Cradle: 375 g | / | Different
Note 2 |
|-------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------------------|
| Compliance
with voluntary
standards | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-1-11;
IEC 60601-2-57;
IEC 62471 | IEC 60601-1;
IEC 60601-1-2;
IEC 62471-1 | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-1-11;
IEC 60601-2-57;
IEC 62471 | Same |
| Biocompatibility feature | All body-contacting
materials are complied
with ISO10993-5 and
ISO 10993-10 | All body-contacting
materials are
complied
with
ISO10993-5 and ISO
10993-10 | All body-contacting
materials are complied
with ISO10993-5 and
ISO 10993-10 | Same |
Comparison in details:
Note 1:
The power supply for the subject device is different from that of the predicate device, however the lithium battery of the subject device has passed IEC62133-2 test and the power adapter has been assessed for electrical safety along with the main unit, so this difference should not raise any safety/effectiveness questions.
Note 2:
Although the appearance, weight and dimensions are different between the subject and predicate device, these differences are insignificant and do not raise any safety/effectiveness problems.
(9) Non-clinical studies and tests performed:
Non-clinical testings have been conducted to verify that the Beauty LED Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:
- A ANSI AAMI ES 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- A 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
- A 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
- A 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
7
- IEC 62471, Photobiological safety of lamps and lamp systems A
- A IEC 62133-2, 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
The device has been tested for biocompatibility, it complies with the following standards.
- A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted:
- Software verification and validation test according to the requirements of the FDA "Guidance A for Pre Market Submissions and for Software Contained in Medical Devices"
(10) Conclusion
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Beauty LED Mask is found to be substantially equivalent to the predicate device, K183671, LG PRA.L DERMA LED MASK.