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.

AI/ML Overview

The provided document is a 510(k) summary for the Beauty LED Mask, Model: KFB265. It outlines the device's characteristics and its substantial equivalence to a predicate device, but it does not contain information about clinical studies or specific acceptance criteria and performance data related to its effectiveness in treating wrinkles and acne.

The document primarily focuses on:

Regulatory classification and product codes.
Comparison of technological characteristics with predicate devices (e.g., light source, wavelength, power supply, dimensions).
Compliance with non-clinical standards, such as electrical safety (IEC 60601 series, IEC 62133-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993 series).
Software verification and validation.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and reported device performance for clinical outcomes.
Sample size and data provenance for a test set.
Number and qualifications of experts for ground truth establishment.
Adjudication method for the test set.
Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone algorithm performance.
Type of ground truth used (clinical outcomes, pathology, etc.).
Sample size and ground truth establishment for a training set.

The document states that "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." This indicates that the 510(k) clearance was based on demonstrating equivalence in non-clinical technical characteristics and safety, rather than requiring new clinical performance data for effectiveness.

In summary, the provided text describes a regulatory submission based on substantial equivalence to a predicate device through non-clinical testing, not a study proving clinical effectiveness against specific acceptance criteria.

Summary

{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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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, TongzipoWest 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:

(6) Indications for use:

The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

Componentname	Material of Component	Body Contact Category	Contact Duration
Beauty LEDMask	ABS, Silicone	Surface-contactingdevice: 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 DERMALED MASK	MMSphere™	/
510 (k) number	Applying	K183671	K190443	/
Manufacturer	Hunan GuangyeBiotechnology Co., Ltd.	LG Electronics, Inc.	Galactic Beauty, LLC	/
Regulationnumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Same
Classificationname	Light Based Over TheCounter Wrinkle and	Light Based Over TheCounter Wrinkle	OTC Powered Light forWrinkle 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 intendedto use LED light for thetreatment of wrinklesand mild to moderateacne.	The LG PRA.LDERMA LED MASKis an over the counterdevice that is intendedfor the use in thetreatment of full facewrinkles.	MMSphereTM LightTherapy Device emitsenergy in the red, blueand amber regions of thespectrum,specifically indicated totreat wrinkles and/ormild to moderate acne.The MMSphereTM isdesigned to be used for20 minute treatmentsthree to seven times perweek.	Similar
Location for use	Face	Face	Face	Same
OTC or prescription	OTC	OTC	OTC	Same
Power supply	Input: 100 -240 V ~ 50 /60 HzOutput: 5V 1A	Input: AC 100V ~/240VFrequency: 50Hz/60HzOutput: 5V 2A		DifferentNote 1
Light source	Light Emitting Diodes(LED)	Light Emitting Diodes(LED)	Light Emitting Diodes(LED)	Same
Wavelength	Red (637nm±5nm) andIR (854nm±5nm);Blue (465±5nm)	RED (637nm) and IR(854nm)	465nm605nm625nm	Similar
LED power	Red+IR: 25.5mW/cm²Blue: 1.36mW/cm²	Red+IR: 25mW/cm²	Red: 2.45mW/cm²Blue: 1.33mW/cm²	Similar
Treatment time	10min each time	9 minutes daily5 days per week for 8weeks	20mins/day,120 days	Similar
Mask design	Yes	Yes	Handheld or placed ona countertop	Same
Dimensions(mm)	LED Mask:Approximately 183 mmx 238 mm x 98 mmController: 100mm x 50mm x 21.5 mm	LED Mask: 180 x/214.5 x 92.4Controller: 41 x 31 x103		DifferentNote 2

{6}------------------------------------------------

Weight	245g	LED Mask: 207 gController: 82 gAdaptor: 75 gCradle: 375 g	/	DifferentNote 2
Compliancewith voluntarystandards	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-contactingmaterials are compliedwith ISO10993-5 andISO 10993-10	All body-contactingmaterials arecompliedwithISO10993-5 and ISO10993-10	All body-contactingmaterials are compliedwith ISO10993-5 andISO 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.

Regulation Number and Section

§ 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.