LED Light Therapy Mask is a home use wearable LED phototherapy device which can help reduce facial wrinkles and mild to moderate inflammatory acne. LED Light Therapy Mask is consisting of main unit (mask), controller, Type-C charging cable and so on. There are 4 kinds of light, including Red light (wavelength 630nm), Blue light (wavelength 415nm), Amber light (wavelength 605nm), Infrared light (wavelength 850nm).

The M01, M02, M06, M07, M08 output 4 kinds of treatment modes: red+infrared, red, amber, blue. The M09 outputs 3 kinds of treatment modes: red+infrared, amber, blue+red+infrared.

AI/ML Overview

This FDA 510(k) clearance letter does not describe a study that proves the device meets acceptance criteria. Rather, it indicates clearance due to substantial equivalence to predicate devices based on non-clinical testing.

Here's a breakdown of why the requested information cannot be provided from the given document:

No Clinical Study Details: The document explicitly states "Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b))" and then lists only non-clinical tests (ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471). There is no mention of any clinical study, patient data, ground truth establishment, or expert reviews.

Therefore, for your subsequent requests regarding acceptance criteria and a study that proves the device meets them, the following answers are based on the absence of such information in the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the document. The clearance is based on substantial equivalence to predicate devices, implying performance comparable to those devices rather than specific quantitative acceptance criteria for clinical efficacy.
Reported Device Performance: Not reported in clinical terms. The document only references non-clinical testing for safety and electrical performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as no clinical study test set is described. The non-clinical tests would have involved specific samples (e.g., device units, materials for biocompatibility) but these are not "test sets" in the context of clinical performance evaluation.

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 as no clinical study with a test set requiring ground truth establishment is described.

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

Not applicable as no clinical study with a test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done, nor is there any mention of AI in this device. This is an LED light therapy mask, not an AI diagnostic tool.

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

Not applicable as this is an LED light therapy mask, not an algorithm or AI device.

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

Not applicable as no clinical study requiring ground truth is described.

8. The sample size for the training set

Not applicable as this is an LED light therapy mask; there is no mention of machine learning or an algorithm requiring a training set.

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

Not applicable as this is an LED light therapy mask; there is no mention of machine learning or an algorithm requiring a training set with established ground truth.

Summary of what is contained in the document regarding "proof" of meeting criteria:

The FDA clearance for the LED Light Therapy Mask (K251667) is based on substantial equivalence to legally marketed predicate devices, not on a new clinical study demonstrating specific efficacy or performance criteria. The "proof" provided in the 510(k) summary focuses on non-clinical testing and technological comparisons:

Non-Clinical Testing:
- Biological evaluation (ISO 10993-1:2018)
- Electrical safety (IEC 60601-1:2020)
- Electromagnetic compatibility (IEC 60601-1-2:2020)
- Home healthcare environment requirements (IEC 60601-1-11:2020)
- Specific requirements for home light therapy equipment (IEC 60601-2-83:2022)
- Photobiological safety (IEC 62471:2006)
Technological Comparison (Substantial Equivalence): The device's indications for use, power supply (lithium batteries tested per IEC 62133-2), LED wavelengths (red: 630nm, amber: 605nm, blue: 415nm, infrared: 850nm), irradiance levels, and safety features (Type BF applied part) were found to be similar or within the acceptable range of the predicate and reference devices.

Summary

FDA 510(k) Clearance Letter - LED Light Therapy Mask

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U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.08.00
Silver Spring, MD 20993
www.fda.gov

August 7, 2025

Shenzhen Liyoutong Technology Co., Ltd.
℅ Riley Chen
RA Specialist
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center, No. 3101-90,
Qianhai Road
Shenzhen, Guangdong 518052
China

Re: K251667
Trade/Device Name: LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
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: May 26, 2025
Received: May 30, 2025

Dear Riley Chen:

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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K251667 - Riley Chen Page 2

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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251667 - Riley Chen Page 3

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,

TANISHA L. HITHE -S Digitally signed by TANISHA L. HITHE -S Date: 2025.08.07 12:39:37 -04'00'

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

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K251667

Please provide the device trade name(s).
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)

Please provide your Indications for Use below.

M01, M02, M06, M07, M08:

Red light: Treatment of full-face wrinkles.
Red+Infrared Light: Treatment of full-face wrinkles.
Amber light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.

M09:

Red+Infrared Light: Treatment of full-face wrinkles.
Amber light: Treatment of full-face wrinkles.
Mixed light: Treatment of mild to moderate inflammatory acne.

Please select the types of uses (select one or both, as applicable).

☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)

LED Light Therapy Mask Page 9 of 35

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510(k) Summary

510(k)#: K251667 Prepared on: 2025-05-30

Contact Details (21 CFR 807.92(a)(1))

Field	Information
Applicant Name	Shenzhen Liyoutong Technology Co., LTD.
Applicant Address	705, 7th Fl., Bldg H, Bantian International Ctr., No.5 Huancheng South Rd., Ma'an Tang Community, Bantian St., Longgang Dist. Shenzhen Guangdong China
Applicant Contact Telephone	86 15521100876
Applicant Contact	Mr. Zhenwen Lai
Applicant Contact Email	laizhanwen@163.com
Correspondent Name	Feiying Drug & Medical Consulting Technical Service Group
Correspondent Address	Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen Guangdong 518052 China
Correspondent Contact Telephone	+86 13660660449
Correspondent Contact	Ms. Riley Chen
Correspondent Contact Email	c3714930@gmail.com

Device Name (21 CFR 807.92(a)(2))

Field	Information
Device Trade Name	LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
Common Name	Laser surgical instrument for use in general and plastic surgery and in dermatology
Classification Name	Light Based Over The Counter Wrinkle Reduction
Regulation Number	878.4810
Product Code(s)	OHS, OLP

Legally Marketed Predicate Devices (21 CFR 807.92(a)(3))

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K241857	LED Light Therapy Device	OHS,OLP, ILY
K192295	LED THERAPY DEVICE	OHS,OLP
K223544	LED light therapy mask	OHS,OLP, ILY

Device Description Summary (21 CFR 807.92(a)(4))

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kinds of light, including Red light (wavelength 630nm), Blue light (wavelength 415nm), Amber light (wavelength 605nm), Infrared light (wavelength 850nm).

The M01, M02, M06, M07, M08 output 4 kinds of treatment modes: red+infrared, red, amber, blue. The M09 outputs 3 kinds of treatment modes: red+infrared, amber, blue+red+infrared.

Intended Use/Indications for Use

M01, M02, M06, M07, M08:

Red light: Treatment of full-face wrinkles.
Red+Infrared Light: Treatment of full-face wrinkles.
Amber light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.

M09:

Red+Infrared Light: Treatment of full-face wrinkles.
Amber light: Treatment of full-face wrinkles.
Mixed light: Treatment of mild to moderate inflammatory acne.

Indications for Use Comparison (21 CFR 807.92(a)(5))

The indications for use of the subject device is comparable to the indications for use of the predicate devices.

Technological Comparison (21 CFR 807.92(a)(6))

The technical characteristics of LED Light Therapy Mask (Models: M01, M02, M06, M07, M08, M09) are substantially equivalent to the predicate device in the following aspects:

the indications for use of LED Light Therapy Mask are within the range of the predicate and reference devices.
similar power supply: the product uses lithium batteries, which were tested according to FDA guidance documents and the requirements of IEC 62133-2, the tests are all passed.
same wavelength: the LED Light Therapy Mask has the same wavelengths (red: 630nm, amber: 605nm, blue: 415nm, infrared: 850nm) as K241857 and K192295, and they all comply with IEC 60601-2-83 and IEC 62471 requirements, so it will not raise any safety or effectiveness issue.
similar irradiance: though the irradiance of subject device is a little different from the predicate device and reference devices, the irradiance of subject device is within the range of the minimum and maximum value of the predicate device and reference devices, and the subject device complies with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue. The evaluation process is as follows:
- a. The Red+IR, Red, Amber irradiance of subject device is similar to the predicate device (K241857)
- b. The mixed light irradiance of subject device is the same as reference device 2 (K223544)
- c. The blue light irradiance of subject device is within the range of the predicate device (K241857) and reference device 1 (K192295)
the same safety features: Type BF applied part.
dimension and weight: though the dimension and weight are a little different from the predicate device and reference devices, this difference is insignificant and do not raise any safety or effectiveness problems.

Therefore, the LED Light Therapy Mask is substantially equivalent to its predicate device and reference predicate devices.

Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b))

The following performance data were provided in support of the substantial equivalence determination.

ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
IEC 60601-1:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2020, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
IEC 60601-1-11:2020, Medical Electrical Equipment-Part 1: 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 60601-2-83: 2022, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
IEC 62471: 2006, Photobiological safety of lamps and lamp systems

Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

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.