This device produces light in the blue light (415mm) is intended to reduce mild to moderate inflammatory acne vulgaris. The red light (635mm) in combination with near-infrared light (850mm) is intended to improve the appearance of wrinkles.

Device Description

The Bestqool LED therapy devices, available in models LMK-001, LMK-004, LMK-005, and LMK-006, differ only in their appearance color to cater to user preferences. The device is designed as a foldable arch shape and is equipped with 200 LED beads. Despite the color variations, the device structure and functional parameters remain identical across all models,which uses specific wavelengths of light to manage aesthetic conditions. This device does not come into contact with the body; users should lie under the device treatment area during use.The device is powered by an AC adapter. This device produces light in the blue light (415nm) is intended to reduce mild to moderate inflammatory acne vulgaris. The red light (635nm) in combination with near-infrared light (850nm) is intended to improve the appearance of wrinkles.

AI/ML Overview

This document is a 510(k) summary for the Bestqool LED Therapy Device. It details the device's indications for use, its comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.

Based on the provided information, the device is an LED Therapy Device (Bestqool LED Therapy Device (LMK-001, LMK-004, LMK-005, LMK-006)) and the submission is a 510(k) Premarket Notification.

Here's an analysis addressing your questions, keeping in mind that this is a 510(k) summary and not a full study report. Therefore, some specific details might be summarized or omitted in this document.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K200983) by showing similar technological characteristics and performance that does not raise new questions of safety and effectiveness. The acceptance criteria are implicitly tied to meeting the performance characteristics demonstrated by the predicate device and relevant safety standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantified table with corresponding "reported device performance" in a manner typical for clinical trials or comprehensive performance testing. Instead, it relies on demonstrating similarity to a predicate device and adherence to recognized safety standards. However, we can infer some criteria and reported performance from the "Predicate Device Comparison" table and "Summary of Non-Clinical Performance Testing".

Feature/Metric	Acceptance Criteria (Implicit, based on Predicate/Standards)	Reported Device Performance (Subject Device)
Indications for Use	Same as predicate: Reduction of mild to moderate inflammatory acne vulgaris (blue light); Improvement of appearance of wrinkles (red + near-infrared light). The predicate also had an indication for pain relief/increased local blood circulation, which the subject device does not claim.	This device produces light in the blue light (415nm) is intended to reduce mild to moderate inflammatory acne vulgaris. The red light (635nm) in combination with near-infrared light (850nm) is intended to improve the appearance of wrinkles. (`Similar to the predicate device HK207 model`)
Wavelengths	Within acceptable range of predicate device's wavelengths (Blue: 465nm, Red: 640nm, Near-infrared: 880nm) for claimed indications.	Blue: 415nm±10nm; Red: 635nm±10nm; Near-infrared: 850nm±10nm (`Same` - in the context of therapeutic equivalence, despite numerical difference outside ±10nm, the FDA likely considers these wavelengths functionally equivalent for the stated indications given the 510(k) pathway and "similar" conclusion.)
Irradiances	Comparable to predicate device's irradiance (6.5 mW/cm2).	7.5mw/cm2±25% (`Same` - indicating it falls within an acceptable range for therapeutic equivalence)
Treatment Dose	Comparable to predicate device's treatment dose (11.7 J/cm2).	13.5 J/cm2±25% (`Same` - indicating it falls within an acceptable range for therapeutic equivalence)
Electrical Safety	Compliance with IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-11:2015 +A1:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-1-6:2010, AMD1:2013, AMD2:2020 (when combined with IEC 62366-1:2015, AMD1:2020), and IEC 60601-2-57 Edition 1.0 2011-01. Photosafety: IEC 62471 First edition 2006-07.	Electrical safety and EMC testing were conducted per the listed standards. (`Testing performed, implied compliance`)
EMC	Compliance with IEC 60601-1-2:2014+A1:2020.	Electrical safety and EMC testing were conducted per the listed standards. (`Testing performed, implied compliance`)
Usability	Compliance with IEC 60601-1-6:2010, AMD1:2013, AMD2:2020 in conjunction with IEC 62366-1:2015, AMD1:2020.	Testing was conducted per the listed standards. (`Testing performed, implied compliance`)
Software V&V	Compliance with 2023 FDA guidance: Content of Premarket Submissions for Device Software Functions, Basic Documentation Level.	Software verification & validation was provided. (`Documentation provided, implied compliance`)
Use Life	Demonstrated viability for 2 years.	The subject device has a use-life of 2-years. (`Claimed & presumably supported by testing`)
Bench Tests	Ensure accurate wavelength, irradiance, and treatment dose output.	Wavelength test, Irradiance test, Treatment dose test. (`Tests conducted, implied successful`)

Study Details (as inferred from a 510(k) Summary):

2. Sample size used for the test set and the data provenance:

Sample size: The document explicitly states "Clinic test: N/A". This means no clinical study (human subject test set) was conducted for this 510(k) submission to prove the device meets acceptance criteria. The approval is based on substantial equivalence to a predicate device, supported by bench testing and adherence to recognized standards.
Data provenance: Not applicable, as no clinical test set was used. The non-clinical testing was likely performed by the manufacturer, Dongguan Laiguang Electronic Technology Co.,Ltd. in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Since no clinical test set was used, there was no ground truth to establish by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set.

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:

Not applicable. This device is an LED therapy device, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a light-emitting therapeutic device, not an algorithm. Its "performance" is its ability to emit light at specific wavelengths and intensities for a duration, which was verified through bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical performance testing (wavelength, irradiance, dose), the "ground truth" would be established by validated measurement equipment and calibration standards. For safety and EMC, it's compliance with the specific parameters and limits defined in the referenced IEC standards.
No clinical ground truth (e.g., patient outcomes, clinical assessments of acne or wrinkles) was established for this submission, as clarified by "Clinic test: N/A".

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning device, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. No training set.

Summary

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January 2, 2025

Image /page/0/Picture/1 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 in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

Dongguan Laiguang Electronic Technology Co.,Ltd. Jiangxiang Wu General Manager Room201,NO.64,DongkangRoad,DalingshanTown Dongguan, Guangdong 523820 China

Re: K242789

Trade/Device Name: Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) 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: September 13, 2024 Received: September 16, 2024

Dear Jiangxiang Wu:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

YAN FU-S Digitally signed
Date: 2025.01.0

Digitally signed by YAN FU -S Date: 2025.01.02 18:54:45 -05'00'

for Tanisha Hithe

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) K242789

Device Name

Bestqool LED therapy device Model: LMK-001LMK-004LMK-005LMK-006

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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K242789 - 510(k) Summary

1. Submitter Information:	Dongguan Laiguang Electronic Technology Co., Ltd.Address:Room201,NO.64,DongkangRoad,DalingshanTown,Dongguan,Guangdong,China.Tel :+86-18824627447E-mail: euliyan2019@outlook.com
2. Contact Person:	Jiangxiang Wu (General Manager)
3. Date prepared:	January 1, 2025
4. Device Information:	Device Name: Bestqool LED therapy deviceModel: LMK-001、LMK-004、LMK-005、LMK-006Regulation Number: 21 CFR 878.4810Regulation Name: Laser surgical instrument for use in general and plasticsurgery and in dermatologyClassification Name: Light Based Over The Counter Wrinkle Reduction(OHS); Over-The-Counter Powered Light Based Laser For Acne (OLP)Product Code: OHS ,OLPRegulatory Class: Class II
5. Predicate DeviceInformation:	Device Name: LED facial light therapy mask (Model: HK207), FlexibleLED light therapy (Model: HK209)Manufacturer: NINGBO HESI ELECTRIC CO., LTD.510(k) Number: K200983The predicate device has not been subject to a design-related recall.
6. Device Description:	The Bestqool LED therapy devices, available in models LMK-001,LMK-004, LMK-005, and LMK-006, differ only in their appearance colorto cater to user preferences. The device is designed as a foldable archshape and is equipped with 200 LED beads. Despite the color variations,the device structure and functional parameters remain identical across allmodels,which uses specific wavelengths of light to manage aestheticconditions. This device does not come into contact with the body; usersshould lie under the device treatment area during use.The device ispowered by an AC adapter.This device produces light in the blue light (415nm) is intended to reducemild to moderate inflammatory acne vulgaris. The red light (635nm) incombination with near-infrared light (850nm) is intended to improve theappearance of wrinkles.
7. Indications for Use:	This device produces light in the blue light (415nm) is intended to reducemild to moderate inflammatory acne vulgaris. The red light (635nm) incombination with near-infrared light (850nm) is intended to improve theappearance of wrinkles.

8. Predicate Device Comparison

The following table compares the intended use and technological characteristics of the subject and predicate device.

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	Subject DeviceBestqool LED therapy deviceModels: LMK-001、LMK-004、LMK-005、LMK-006	Predicate DeviceLED facial light therapymask (Model: HK207),Flexible LED light therapy(Model: HK209)K200983	Comment
Product Code	OHS, OLP	OHS, OLP, ILY	Similar
RegulationNumber	21 CFR 878.4810	21 CFR 878.4810	Same
Class	Class II	Class II	Same
Indication forUse	This device produces light inthe blue light (415nm) isintended to reduce mild tomoderate inflammatory acnevulgaris. The red light (635nm)in combination withnear-infrared light (850nm) isintended to improve theappearance of wrinkles.	The LED FACIAL LIGHTTHERAPY MASK (Model:HK207) is intended to:- The device emitting energyin the blue is intended toreduce the mild to moderateinflammatory acne vulgaris.- The device emitting energyin the red and infraredspectrum is intended for thetreatment of full-facewrinkles.The FLEXIBLE LEDLIGHT THERAPY (Model:HK209) is intended to:- The device emitting energyin the blue is intended toreduce the mild to moderateinflammatory acne vulgaris.- The device emitting energyin the red and infraredspectrum is intended for thetreatment of full-facewrinkles- The device is intended todeliver heat in the IRspectrum to provide topicalheating for the purpose ofelevating tissue temperature;for the temporary relief ofminor muscle and joint pain,arthritis and muscle spasm;relieving stiffness; promotingthe relaxation of muscletissue; and to temporarilyincrease local bloodcirculation.	The proposeddevice'sindications foruse are similarto those of thepredicatedevice HK207model
Power Source(s)	Input:100-240Vac, 0.6A,50/60Hz	Input: 100-240Vac,2.0 A, 50/60Hz	Same
Wavelength(s)(nm)	Blue :415nm±10nmRed :635nm±10nmNear-infrared : 850nm±10nm	465nm, 640nm, 880nm	Same
Irradiances(mW/cm2)	7.5mw/cm2±25%	6.5 mW/cm2	Same
Treatment Dose(J/cm2)	13.5 J/cm2±25%	11.7 J/cm2	Same
Treatment time	4 times a week30-60 minutes session4 weeks	3 times a week for 30min.4 weeks	Similar

Table 1 Comparison Between the Subject and Predicate Device

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Based on the comparison table above, the proposed device and predicate device have the same indications for use, working principle, wavelengths and conformance standards, etc. Furthermore, the proposed device's irradiance and radiation dose are similar to those of the predicate device. Minor differences do not raise new questions of safety and effectiveness and these differences in technological characteristics may be evaluated through performance testing.

9. Summary of Non-Clinical Performance Testing:

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the device per the following standards:

IEC 60601-1:2005+A1:2012+A2:2020, Medical electrical equipment-Part 1: General requirements ● for basic safety, and essential performance.
IEC 60601-1-11:2015 +A1:2020, 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 60601-1-2:2014+A1:2020, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests standard for EMC.
IEC 60601-1-6:2010, AMD1:2013, AMD2:2020 for use in conjunction with IEC 62366-1:2015, AMD1:2020, and IEC 60601- 1:2005, AMD1:2012, AMD2:2020, Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-2-57 Edition 1.0 2011-01 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 First edition 2006-07 Photobiological safety of lamps and lamp systems.Software Verification and Validation Testing

Software verification & validation was provided in accordance with 2023 FDA guidance: Content of Premarket Submissions for Device Software Functions. The documentation level for the subject device is Basic Documentation Level.

Performance Testing and Use Life Verification

The subject device has a use-life of 2-years.
Bench test:Wavelength test , Irradiance test , Treatment dose test.

Clinic test :N/A

10. Conclusion:

The proposed device has technological characteristics that are similar to the predicate devices, and when

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compared to the predicate devices it does not raise new types of questions regarding the safety and efficacy for the above indications for use. Performance testing discussed above was conducted with the device to show that it can perform safely and effectively. The proposed device is considered to be substantially equivalent to the predicate device K200983.

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.