Face Patches (Model: MT-12MC) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne and full-face wrinkles (including periorbital wrinkles).

Device Description

The Face Patches, Model: MT-12MA and MT-12MC is an over-the-counter light emitting diode (LED) device.

Model: MT-12MA can emits 415nm and 630nm energy to treat mild to moderate acne. There is a total of 6 LEDs, providing a power intensity of approximately 30 mW/cm².

Model: MT-12MC has 3 modes (mode 1: 630+415nm, mode 2: 630+830nm, mode 3: 590nm), it can emit 630nm and 415 nm energy to treat mild to moderate acne and provide approximately 30 mW/cm²; 630nm and 830nm energy to treat full-face wrinkles and provide approximately 35 mW/cm²; and 590nm energy to treat wrinkles and provide approximately 35 mW/cm². There is a total of 18 LEDs.

The device components include the device containing two face patches, a controller, a charging cable, 120 Mini Dots, goggles and user manual. The user pastes the device on the treatment area, and the device will shut down automatically after a 3-minute after finishing treatment. Users should adjust the treatment time based on different modes and actual treatment situations. The device has one button, and delivery of therapy requires the operator to depress a physical switch on the device.

AI/ML Overview

This FDA 510(k) summary for the Face Patches (MT-12MA, MT-12MC) indicates that no clinical studies were performed, and therefore, no acceptance criteria based on clinical performance are reported.

The submission relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, asserting that these tests are "sufficient to support that the device can be used safely and effectively."

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical studies were performed, there are no acceptance criteria related to a device's clinical performance (e.g., sensitivity, specificity, accuracy). The acceptance criteria mentioned are related to compliance with recognized standards for electrical safety, electromagnetic compatibility, biocompatibility, and software validation. The reported "performance" in this context is simply compliance with these standards.

Test Category	Acceptance Criteria (Compliance with Standards)	Reported Device Performance
Electrical Safety	IEC 60601-1 ed. 3.2	Complied
	IEC 60601-1-11 ed. 2.1	Complied
	IEC 60601-2-57 ed. 1.0	Complied
EMC	IEC 60601-1-2 ed. 4.1	Complied
Photobiological Safety	IEC 62471 ed. 1.0	Complied
Battery Safety	IEC 62133-2 ed. 1.0	Complied
Biocompatibility	ISO 10993-5 (Cytotoxicity)	Complied
	ISO 10993-10 (Sensitization)	Complied
	ISO 10993-23 (Skin Irritation)	Complied
	ISO 10993-11 (Acute Systemic Toxicity)	Complied
	USP 151 (Material-mediated Pyrogens)	Complied
Software Verification & Validation	FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern)	Testing conducted and documentation provided as recommended.
Usability Validation	IEC 62366-1 and IEC 60601-1-6	Complied
Light Output	Output matches stated specifications	Validated

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set was used. The testing involved non-clinical validation against standards and device specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No ground truth for a clinical test set was established as no clinical studies were conducted. The "ground truth" for the non-clinical tests is represented by the established specifications and requirements of the recognized standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical adjudication method was needed since no clinical studies were performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. No MRMC comparative effectiveness study was done as no clinical efficacy or effectiveness studies were performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a light-emitting device, not an algorithm, so the concept of standalone algorithmic performance is not relevant in the context of typical AI/software device studies.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is primarily defined by:

Recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, IEC 62471, IEC 62133-2).
The device's own design specifications (e.g., for light output, power, irradiance, wavelengths, doses, etc.).
FDA guidance documents (for software validation).

8. The Sample Size for the Training Set

Not applicable. No training set was used as this device is a hardware light-emitting device, not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary

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April 10, 2024

Shenzhen Kaiyan Medical Equipment Co., Ltd Alain Diikstra Official Correspondent Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District Shenzhen, Guangdong 518103 China

Re: K240089

Trade/Device Name: Face Patches (MT-12MA, MT-12MC) 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. GEX Dated: January 9, 2024 Received: January 12, 2024

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 (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.

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).

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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/deviceadvice-comprehensive-regulatory-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. Digitally signed by Hithe -S Date: 2024.04.10 14:46:04 -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

510(k) Number (if known) K240089

Device Name Face Patches (MT-12MA, MT-12MC)

Indications for Use (Describe)

Face Patches (Model: MT-12MA) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.

Face Patches (Model: MT-12MC) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne and full-face wrinkles (including periorbital 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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510(k) Summary of K240089

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Submitter's Information 1.

Sponsor Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Establishment Registration Number: 3011644607 Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: requlation@kaiyanmedical.com

Application Correspondent:

Contact Person: Alain Diikstra Company: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Tel: +86 755 82129361 Fax: +86 755 25024651 Email: requlation@kaiyanmedical.com

2. Subject Device Information:

Trade Name: Face Patches, model: MT-12MA, MT-12MC Classification Name: Over-The-Counter Powered Light Based Laser For Acne. Light based over the counter wrinkle reduction, Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgery Product Code: OHS, OLP, GEX Regulation Number:21 CFR 878.4810 Regulation Class: II

3. Predicate Device Information Predicate Device 1 (K230720)

Sponsor: Light Tree Ventures Europe B.V.

Trade Name: LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 Classification Name: Over-The-Counter Powered Light Based Laser For Acne, Light based over the counter wrinkle reduction, Laser surgical instrument for use in general and plastic surgery and in dermatology

Review Panel: General & Plastic Surgery Product Code: OLP Regulation Number: 21 CFR 878.4810 Regulation Class: II

Predicate Device 2 (K221946)

Sponsor: Light Tree Ventures Europe B.V. Trade Name: LED LIGHT THERAPY MASK, model: MK66R-B Classification Name: Light based over the counter wrinkle reduction Review Panel: General & Plastic Surgery Product Code: OHS Requlation Number: 21 CFR 878.4810 Regulation Class: II

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Predicate Device 3 (K200104)

Sponsor: RAJA Trading Company, Inc. Trade Name: OxyLight Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgery Product Code: GEX, GFE Requlation Number: 21 CFR 878.4810, 21 CFR 878.4820 Regulation Class: II

Device Description 4.

The Face Patches, Model: MT-12MA and MT-12MC is an over-the-counter light emitting diode (LED) device.

Model: MT-12MA can emits 415nm and 630nm energy to treat mild to moderate acne. There is a total of 6 LEDs, providing a power intensity of approximately 30 mW/cm².

Intended Use / Indications for Use 5.

Face Patches (Model: MT-12MA) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.

Face Patches (Model: MT-12MC) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne and full-face wrinkles (including periorbital wrinkles).

Comparison to predicate devices 6.

Compare with the predicate devices, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between the subject device and predicate devices do not raise new questions of safety or effectiveness.

Elements ofComparison	Subject device	Predicate device(K230720)	Predicatedevice(K221946)	Predicate device(K200104)	Remark
Company	Shenzhen KaiyanMedical EquipmentCo., Ltd	Light TreeVentures EuropeB.V.	Light TreeVentures EuropeB.V.	RAJA TradingCompany, Inc.	--
Trade Name	Face Patches	LUSTRE3XPRESS LightBeauty Therapypatches	LED LIGHTTHERAPYMASK	OxyLight	--
Model	MT-12MA, MT-12MC	PR6001, PR5001	MK66R-B	--	--
510 (K) Number	K240089	K230720	K221946	K200104	--
RegulationClass	Class II	Class II	Class II	Class II	Same
Indications forUse / Intended	Face Patches(Model: MT-12MA)	The LUSTRE3XPRESS Light	The LED LIGHTTHERAPY	The Oxylight isintended for	Different,note 1
Elements ofComparison	Subject device	Predicate device(K230720)	Predicatedevice(K221946)	Predicate device(K200104)	Remark
use	is an Over-the-Counter (OTC)device intended fortreatment of mildto moderateinflammatory acneFace Patches(Model: MT-12MC) isan Over-the-Counter (OTC)device intended fortreatment of mildto moderateinflammatory acneand full-facewrinkles (includingperiorbitalwrinkles).	Beauty Therapypatches (Model:PR6001, PR5001) isan Over-the-Counter (OTC)device intended forthe treatment ofmild to moderateacne.	MASK(MK66R-B) is anover-the-counterdevice that isintended for theuse inthe treatment offull-face wrinkles.	dermatological useby physicians andhealthcareprofessionals for thefollowing: LEDTechnology isintended for: -BlueLED – 465nm – totreat dermatologicalconditions andspecificallyindicated to treatmoderateinflammatory acnevulgaris. -Red LED625nm- fortreatment ofsuperficial, benignvascular andpigmented lesions. -Yellow LED 590nm- treatment ofperiorbital wrinklesand rhytides.Microdermabrasionis intended forexfoliation of theskin. Oxygen sprayis intended torefresh the skin.
Power Source	Controller: 3.6V,65mAh lithiumbattery, 0.234Wh	Input: 100-240Va.c.,50Hz/60Hz;output: 5Vd.c., 2A	Input: 100-240Va.c.,50Hz/60Hz,Output: 5Vd.c.,2A.	not available	Different,note 2
Wavelengths	MT-12MA:$630 \pm 10nm$$415 \pm 10nm$MT-12MC: $415nm \pm$$10nm, 630nm \pm$$10nm, 830nm \pm$$10nm, 590nm \pm$10nm	$630 \pm 10nm$$415 \pm 10nm$	Red: 630±5nmNIR: 830nm	590 nm +/- 5nm	Similar,note 3
Irradiancesource	LED	LED	LED	LED	Same
LED number	For MT-12MA:415nm: 6630nm: 6	Blue: 12 Red: 12Total 24	630+/-5nm: 66830nm: 66	not available	Differentnote 4
Elements ofComparison	Subject device	Predicate device(K230720)	Predicatedevice(K221946)	Predicate device(K200104)	Remark
	For MT-12MC:415nm: 6630nm: 12 (twotype)830nm: 6590nm: 6Total 18 LEDs
	Intendedlocation Use	Face	Face	Face	Face
Irradiance(mW/cm2)	For MT-12MA:630nm: 5415nm: 25630+415nm: 30For MT-12MC:630nm (type 1): 5415nm: 25Mode 1 - total: 30830nm: 15630nm (type 2): 20Mode 2 - total: 35Mode 3 - 590nm:35	Red: 5Blue: 25630+415nm: 30	630+/-5: 15-20830nm: 10-15630+830nm: 30	Yellow (590nm): 35	Similar,note 5
Dose / pertime(J/cm2)	For MT-12MA:630+415nm: 5.4For MT-12MC:630+415nm: 5.4630+830nm: 18.9590nm: 44.1	630+415nm: 5.4	630+830nm: 18	590nm: 42	Similar,note 5
LED distribution	Uniformdistribution	Uniformdistribution	Uniformdistribution	Uniform distribution	Same
Treatment Time	For MT-12MA(630+415nm):3 minutes pertreatmentFor MT-12MC(mode 1 -630+415nm): 3minutes pertreatmentFor MT-12MC(mode 2 -630+830nm): 9minutes per	3 minutes pertreatment	10 minutes pertreatment	20 minutes	Similar,note 5
Elements ofComparison	Subject device	Predicate device(K230720)	Predicatedevice(K221946)	Predicate device(K200104)	Remark
	treatmentFor MT-12MC(mode 3 - 590nm):21 minutes pertreatment
EMC	IEC60601-1-2	IEC60601-1-2	IEC60601-1-2	IEC 60601-1-2	Same
Safety	IEC60601-1IEC60601-2-57IEC60601-1-11IEC62471IEC 60601-1-6	IEC 60601-1IEC 60601-2-57IEC 60601-1-11IEC 62471	IEC 60601-1IEC 60601-2-57IEC 60601-1-11IEC 62471IEC 62366-1 &IEC 60601-1-6	IEC 60601-1, EN60601-1-2	Same
Biocompatibility	ISO 10993-1ISO10993-5ISO10993-10ISO 10993-23ISO 10993-11	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-23ISO 10993-11	ISO 10993-1,ISO 10993-5,ISO 10993-10	not available	Same

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Comparison in Detail(s):

Note 1: Although the "Indications for Use / Intended use" is a little different from the predicate devices, the acne removal function of the model MT-12MA and MT-12MC (mode1) of subject device is consistent with predicate device (K230720), the wrinkle removal function of the model MT-12MC (mode 2) of subject device is consistent with predicate device (K221946), the wrinkle removal function of the model MT-12MC (mode 3) of subject device is consistent with predicate device (K200104). So, this difference will not affect the safety and effectiveness of the subject device.

Note 2: Although the "Power Supply" is a little different from the predicate devices, they all complied with the IEC 60601-1, IEC 62133-2, and IEC 60601-1-2 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issues.

Note 3: The wavelengths of the subject device can be covered by the predicate device. The wavelength of MT-12MA and MT-12MC Mode 1 is 630nm and 415nm, which is consistent with the predicate device 1 (K230720); The wavelength of MT-12MC Mode 2 is 830nm which is consistent with the predicate device 2 (K221946); The wavelength of MT-12MC Mode 3 is 590nm which is consistent with the predicate device 3 (K200104).

So, the treatment wavelength of the subject device is acceptable.

Note 4: Although the "Number of LEDs" is different from the predicate devices, it will not change the irradiance which is similar. So, these differences will not raise any safety or effectiveness issues.

Note 5: Although the "Irradiance", "Dose / per time" and "Treatment Time" are a little different from the predicate devices, the values of each treatment for these parameters are very close. Dose is equal to Irradiance (W/cm²) * Time (s). Through calculation, it can be concluded that the dose of the subject device at 630+415nm is 0.03 * 3 * 60=5.4J/cm², which is consistent with the dose of the predicate device (K230720) at 0.03 * 3 * 60=5.4J/cm²; The dose of subject device 830+630nm is 0.035 * 9 * 60=18.9J/cm², which is similar to the dose of predicate device (K221946) of 0.03 * 10 * 60=18J/cm², and the dose of

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590nm is 0.035 * 21 * 60=44.1J/cm², which is similar to the dose of predicate device (K200104) of 0.035 * 20 * 60=42J/cm². So, these differences will not raise any safety or effectiveness issues.

7. Test Summarv

7.1 Non-Clinical Tests Performed

1) Electrical safety, and electromagnetic compatibility Test

Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:

IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment Part 1: General requirements for basic � safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
� IEC 60601-1-11 Edition 2.1 2020-07 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 60601-2-57 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 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
� IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems.
� IEC 62133-2 Edition 1.0 2017-02 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.

2) Biocompatibility Test

The subject device is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-23 (Skin Irritation) and ISO 10993-11 (Acute Systemic Toxicity and Material-mediated Pyrogens) and USP 151.

3) Software verification and validation

Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.

4) Usability validation

Usability testing was conducted on the Face Patches (Models: MT-12MC), which complies with IEC 62366-1 and IEC 60601-1-6.

5) Light output

The Light output test validated that the output of light from the devices are the same as stated in the specifications.

7.2 Summary of Clinical Performance

Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.

8. Date of the summary prepared: April 9, 2024

9. Final Conclusion

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The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K230720, K221946 and K200104.

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.