For MK-90C:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90C) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris of the face and use in the treatment of full-face wrinkles.
For MK-90M:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90M) is an over the counter device intended for the use in the treatment of full face wrinkles.
For MK66RB-F:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK66RB-F) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris.
For MK-90N:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90N) is an over the counter device, is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles.

Device Description

The CurentBody™LED 4 in 1 Zone Facial Mapping Mask is a home wearable light-emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of mild to moderate acne vulgaris of the face. The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by adjustable Velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface, Both surfaces are constructed of silicone The CurentBody™LED 4 in 1 Zone Facial Mapping Mask has 4 models, MK-90C, MK-90M, MK66RB-F and MK-90N.The controller contains a rechargeable lithium battery. The user charges the controller by connecting the charging cable with an adapter (AC100-240V, 50Hz/60Hz 5V 2A).The LED Light Therapy Mask cannot be operated while charging.

AI/ML Overview

This document describes the FDA's decision to clear the CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask based on its substantial equivalence to previously marketed devices. As such, it does not include a detailed study proving the device meets acceptance criteria specific to a new AI/imaging algorithm. Instead, it relies on demonstrating that the new device is as safe and effective as existing, cleared devices through non-clinical testing and comparison.

Therefore, many of the specific questions about AI/imaging algorithm acceptance criteria, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this 510(k) submission, which is for a light therapy device.

However, I can extract information related to the device's technical specifications and how its performance and safety were evaluated against predicate devices.

Here's a breakdown of the available information, addressing the relevant points and noting where information is not applicable due to the nature of the device and submission type:

1. Table of acceptance criteria and reported device performance:

The document doesn't present "acceptance criteria" in the traditional sense of a specified performance threshold (e.g., >X% accuracy). Instead, the acceptance criteria for this 510(k) submission are implicitly met by demonstrating substantial equivalence to predicate devices in areas of safety and effectiveness. The "reported device performance" is largely framed as compliance with recognized standards and similarity to the predicate devices.

Feature/Test	Acceptance Criteria (Implied by Predicate Equivalence & Standards Compliance)	Reported Device Performance
Product Code	Same as predicate devices (OHS, OLP)	OHS, OLP
Regulation Number	Same as predicate devices (21 CFR 878.4810)	21 CFR 878.4810
FDA Device Classification	Same as predicate devices (Class II)	Class II
Use	Over The Counter	Over The Counter
Indications for Use	Similar to predicate devices: treatment of mild to moderate acne vulgaris of the face (MK-90C, MK66RB-F), full-face wrinkles (MK-90C, MK-90M), periorbital wrinkles (MK-90N), and generally dermatological conditions.	MK-90C: Treat mild to moderate acne vulgaris of the face and full-face wrinkles. MK-90M: Full face wrinkles. MK66RB-F: Treat mild to moderate acne vulgaris. MK-90N: Generally dermatological conditions and specifically periorbital wrinkles. Noted as "Similar" to predicates.
Intended Location of Use	Face	Face
Energy Type	Light Emitting Diodes	Light Emitting Diodes
Wavelengths	Within or covered by the variance range of predicate devices. Device passed IEC 60601-2-57.	MK-90C: Red + Infrared (633nm+830nm), Blue + Red (415nm+633nm), Yellow + Infrared (590nm+830nm). MK-90M: Red + Infrared (633nm+830nm). MK66RB-F: Red + Blue (633nm+415nm). MK-90N: Yellow + Infrared (590nm+830nm). Noted as "Similar" and covered by predicate's ±10nm variance.
Power Density	Power density should not raise new safety concerns compared to predicates. Lower effective irradiance compared to secondary predicate is acceptable.	415nm: 25±5mW/cm²; 633nm: 20±5mW/cm²; 590nm: 15±5mW/cm²; 830nm: 10±5mW/cm². Noted as "Different" but acceptable as proposed device's effective irradiance is less than secondary predicate's, indicating no increased safety concerns.
LED Distribution	Uniform distribution	Uniform distribution
Treatment Time	Similar to predicate devices (e.g., 10 minutes)	10 minutes (for some modes/models, other predicate times vary, but considered "Same" or acceptable).
Treatment Protocol	Similar to predicate devices (e.g., 5x weekly for 6 weeks for wrinkles, 4x weekly for 6 weeks for acne).	Wrinkles: 5 x weekly, 6 weeks; Acne: 4 x weekly, 6 weeks.
Software Controlled	Device uses a timer and software to control treatment duration.	Device uses a timer and software to control treatment duration.
Biocompatibility	No Cytotoxicity, No Skin Sensitization, No Irritation. Compliance with ISO 10993-5, 10993-10, 10993-23.	No Cytotoxicity, No evidence of skin sensitization, No irritation. Compliant with ISO 10993-5, 10993-10, 10993-23.
Electrical Safety	Comply with IEC 60601-1, IEC 60601-1-11 (Home Healthcare Environment).	Comply with IEC 60601-1, IEC 60601-1-11.
Electromagnetic Compatibility (EMC)	Comply with IEC 60601-1-2.	Comply with IEC 60601-1-2.
Photobiological Safety	Comply with IEC 62471. Compliance with IEC 60601-2-57 (Particular requirements for non-laser light source equipment).	Comply with IEC 62471, IEC 60601-2-57.
Software Verification & Validation (V&V)	Software V&V conducted as per FDA guidance for "basic level concern" software; no "minor injury" from malfunction/latent design flaw expected.	Software V&V testing conducted and documentation provided as recommended by FDA guidance. Software classified as "basic level concern."
Light Output Test	Output of light consistent with specifications.	Validated that the output of light is as stated in the specifications.

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

Sample Size: Not applicable. This submission relies on substantial equivalence through non-clinical performance and safety testing against recognized standards, and comparison to predicate devices, rather than a clinical trial with a "test set" of patients.
Data Provenance: Not applicable in the context of patient data. The provenance of the testing data would be from the manufacturer's internal labs or contracted testing facilities for engineering, electrical, and biocompatibility tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is not an AI/imaging algorithm that requires ground truth established by experts for a test set. Its performance relies on physical specifications, light output, electrical safety, and biocompatibility, as measured against engineering standards.

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

Not applicable. There is no "test set" of patient cases requiring adjudication by experts.

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 is a light therapy device, not an AI-assisted diagnostic tool.

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

Not applicable. This device does not have a standalone algorithm for diagnostic or interpretative performance.

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

Not applicable. "Ground truth" in the context of clinical outcomes or imaging interpretation is not relevant here. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized international and electrical safety standards (e.g., IEC 60601 series, IEC 62471, ISO 10993 series) and demonstration that its physical and functional characteristics are "substantially equivalent" to already cleared predicate devices.

8. The sample size for the training set:

Not applicable. The device is not based on a machine learning model that requires a training set.

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

Not applicable. The device is not based on a machine learning model that requires ground truth for a training set.

Summary of Study Type:

The "study" that proves this device meets the "acceptance criteria" (defined as substantial equivalence to predicates and compliance with safety standards) is a non-clinical performance and safety testing program, as outlined in section 5.1 and 5.2 (Non-Clinical Test, Biocompatibility Test, Light output, and Software verification and validation). No clinical studies were deemed necessary for this 510(k) submission, as stated in section 5.5. The performance is assessed through technical specifications and their adherence to established safety and performance norms for similar devices.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 14, 2025

Shenzhen Kaiyan Medical Equipment Co., Ltd Alain Dijkstra CEO Building#3 and Building#5, 40th of Fuxin Street Huaide Community Fuyong Town Shenzhen, Guangdong 518103 China

Re: K242593

Trade/Device Name: CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) 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: January 17, 2025 Received: January 17, 2025

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/cdrb/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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 (OS) 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 Re"). 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.

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

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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,

Digitally signed by TANISHA TANISHA L. HITHE -S L.HITHE -○ Date: 2025.02.14
14:11:56 -05 16:11:56 -05'00'

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

Submission Number (if known)

K242593

Device Name

CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90M, MK66RB-F, MK-90N)

Indications for Use (Describe)

For MK-90C:

The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90C) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris of the face and use in the treatment of full-face wrinkles.

For MK-90M:

The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90M) is an over the counter device intended for the use in the treatment of full face wrinkles.

For MK66RB-F:

The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK66RB-F) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris.

For MK-90N:

The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90N) is an over the counter device, is generally indicated to treat dermatological conditions and specifically indicated for treatment of 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 K242593

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

1.Submitter's Information

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: registrar01@kaiyanmedical.com

Application Correspondent

Contact Person (including title): Alain Dijkstra (Manager) Company: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Shenzhen, Guangdong 518103, China Shenzhen Guangdong 518103 China Tel: +86-135-10378748 Fax: +86-755-25024651 Email: registrar01@kaiyanmedical.com

Distributor:

Company: CurrentBody.Com Ltd Address: Q17, Crossley Road, Stockport, Greater Manchester, SK4 5BB United Kingdom

2.Subiect Device Information: Device Name:

Device Trade Name: CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) 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: 21 CFR 878.4810 Product Code(s): OHS, OLP

Device Description Summary

Intended Use/ Indications for Use:

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K242593

For MK-90C:

The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: Mk-90C) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris of the face and use in the treatment of full-face wrinkles

For MK-90M:

The CurrentBody™ LED 4in 1 Zone Facial Mapping Mask(Models: MK-90M is an over the counter device intended for the use in the treatment of full face wrinkles.

For MK66RB-F:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK66RB-F) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris.

For MK-90N:

The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask(Models: MK-90N) is an over the counter device, is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles.

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K214103	Shani Darden LED light therapy mask	OLP, OHS
K240089	Face Patches (MT-12MA, MT-12MC)	OHS, OLP, GEX

3.Legally Marketed Predicate Devices:

4.General Comparison:

Item	Subject DeviceCurrentBody™ LED 4 in 1Zone Facial MappingMask(K242593)	Predicate Device 1Shani Darden LED lighttherapy(K214103)	Predicate Device 2Face Patches(MT-12MA,MT-12MC) (K240089)	Remark
Product Code	OHS, OLP	OLP, OHS	OHS, OLP, GEX	Same
Regulation Number	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Same
FDA DeviceClassification	Class II	Class II	Class II	Same
Use	Over The Counter	Over The Counter	Over The Counter	Same
Item	Subject DeviceCurrentBody™ LED 4 in 1Zone Facial MappingMask(K242593)	Predicate Device 1Shani Darden LED lighttherapy mask(K214103)	Predicate Device 2Face Patches(MT-12MA,MT-12MC) (K240089)	Remark
IndicationsforUse	For MK-90C:The CurrentBody™ LED 4in 1 Zone Facial MappingMask (Models: MK-90C) isan over the counter device,specifically indicated to treatmild to moderate acnevulgaris of the face anduse in the treatment offull-face wrinkles.For MK-90M:The CurrentBody™ LED 4in 1 Zone Facial MappingMask (Models: MK-90M) isan over the counter deviceintended for the use in thetreatment of full facewrinkles.For MK66RB-F:The CurrentBody™ LED 4in 1 Zone Facial MappingMask (Models: MK66RB-F)is an over the counterdevice, specifically indicatedto treat mild to moderateacne vulgaris.For MK-90N:The CurrentBody™ LED 4in 1 Zone Facial MappingMask (Models: MK-90N) isan over the counter device,is generally indicated totreat dermatologicalconditions and specificallyindicated for treatment ofperiorbital wrinkles.	The Shani Darden LEDlight therapy mask is anover-the-counter deviceintended to emit energyin the red and blueregion of the lightspectrum, specificallyindicated to treat mild tomoderate acne vulgarisof the face.The Shani Darden LEDlight therapy mask is anover-the-counter deviceintended to emit energyin the red and NearInfra-red spectrum and isintended for the use inthe treatment of full-facewrinkles.	Face Patches (Model:MT-12MA) is anOver-the-Counter(OTC) deviceintended for treatmentof mild to moderateinflammatory acne.Face Patches (Model:MT-12MC) is anOver-the-Counter(OTC) deviceintended for treatmentof mild to moderateinflammatory acneand full-facewrinkles (includingperiorbital wrinkles).	SimilarNote 1
Intended locationof use	Face	Face	Face	Same
Item	Subject Device	Predicate Device 1	Predicate Device 2	Remark
	CurrentBody™ LED 4 in 1Zone Facial MappingMask(K242593)	Shani Darden LED lighttherapy mask (K214103)	Face Patches(MT-12MA, MT-12MC)(K240089)
EnergyType	Light emitting diodes	Light emitting diodes	Light emitting diodes	Same
Wavelengths	MK-90CMode 1: Red + Infrared(633nm+830nm)Mode 2: Blue + Red(415nm+633nm)Mode 3: Yellow + Infrared(590nm+830nm)MK-90MMode: Red + Infrared(633nm+830nm)MK66RB-FMode: Red + Blue (633nm+415nm)MK-90NMode: Yellow + Infrared(590nm+830nm)	Blue: 415nm +/- 10nmRed: 630nm +/- 10nmNIR 830nm +/-10nm	MT-12MA: 415 ± 10nmand 630 ± 10nm;MT-12MC has 3 modes:Mode 1: 630 ± 10nm and415 ± 10nm,Mode 2: 630 ± 10nm and830nm ± 10nm,Mode 3: 590nm ± 10nm	SimilarNote 2
PowerDensity	415nm: 25±5mW/cm²;633nm: 20±5mW/cm²;590nm: 15±5mW/cm²;830nm: 10±5mW/cm²	Blue: 28 mW/cm²Red: 16 mW/cm²andRed: 18 mW/cm²NIR: 11 mW/cm²	For MT-12MA:630nm: 5 mW/cm²415nm: 25 mW/cm²630+415nm: 30 mW/cm²For MT-12MC:630nm (type 1): 5mW/cm²415nm: 25 mW/cm²Mode 1 - total: 30mW/cm²830nm: 15 mW/cm2630nm (type 2): 20mW/cm²Mode 2 - total: 35mW/cm²Mode 3 - 590nm: 35mW/cm²	DifferentNote 3
LEDdistribution	Uniform distribution	Uniform distribution	Uniform distribution	Same
Treatment Time	10 minutes	10 minutes	ForMT-12MA(630+415nm):3 minutes per treatmentFor MT-12MCN(mode 1 -630+415nm):3 minutes per treatmentFor MT-12MC (mode 2 -630+830nm):9 minutes per treatmentFor MT-12MC (mode 3 -590nm):	Same
Item	Subject Device	Predicate Device 1	Predicate Device 2	Remark
Treatment protocol	CurrentBody™ LED 4 in 1Zone Facial MappingMask(K242593)	Shani Darden LED lighttherapy mask (K214103)	Face Patches(MT-12MA, MT-12MC)(K240089)	Same
SoftwareControlled	Device uses a timer andsoftware to control treatmentduration	Device uses a timer andsoftware to control treatmentduration	User interface softwareallows the operator toaccess and control alldevice functions.	Same
Powersupply	MK-90C and MK-90N:3.7Vdc, 5200mAh , 19.24WhLithium batteryMK66RB-F and MK-90M:3.7Vdc, 2600mAh , 9.62WhLithium battery	100-240V	Controller: 3.6V, 65mAhlithium battery, 0.234Wh	DifferentNote 4
Powerinput/output	Adapter Input:100-240Vac,50-60HzOutput: DC 5V,2A	Electrical Input to poweradaptor: 100v-240v.50/60Hz. Rated at 0.7A.Electrical Output from poweradaptor: 12V, 1A	NA	Same
	Wrinkles: 5 x weekly, 6weeksAcne: 4 x weekly, 6 weeks	Wrinkles: 5 x weekly, 6weeksAcne: 4 x weekly, 6 weeks

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Performance Comparison:

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Safety Comparison:

Item	Subject Device	Predicate Device 1	Predicate Device 2	Remark
	CurrentBody ™ LED 4 in1 Zone Facial MappingMask (K242593)	Shani Darden LED lighttherapy mask(K214103)	Face Patches (MT-12MA,MT-12MC) (K240089)
Biocompatibility
Cytotoxicity Irritation	No Cytotoxicity Irritation	No Cytotoxicity Irritation	No Cytotoxicity Irritation
Skinsensitization	No evidence of skinsensitization	No evidence of skinsensitization	No evidence of skinsensitization	Same
Irritation	No irritation	NA	No irritation
EMC, Electrical Safety
Electricalsafety	Comply with IEC 60601-1	Comply with IEC60601-1	Comply with IEC 60601-1	Same
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Comply with IEC 60601-1-2	Same
Home Use	Comply with IEC 60601-11	Comply with IEC60601-11	The proposed device isPrescription Use andoperated by professionalpersonnel, so it does notneed to be tested by IEC60601-1-11	Same

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ParticularRequirements	Comply with IEC60601-2-57	Comply with IEC60601-2-57	Comply with IEC60601-2-57	Same
Photobiological safety	Comply with IEC 62471	Comply with IEC 62471	Comply with IEC 62471	Same

Difference Analysis

Note 1: Although the "Indications for Use / Intended use" is a little different from the predicate devices, the acne treat function of the model MK-90C(mode 2) and MK66RB-F of subject device is consistent with predicate device 2 (Model: MT-12MA, K240089), the wrinkle removal function of the model MK-90C (mode 1,3), MK-90M and MK-90N of subject device is consistent with predicate device 1 (K214103) and predicate device 2 (Model: MT-12MC, K240089). So, this difference will not affect the safety and effectiveness of the subject device.

Note 2: The light wavelength is very similar but not identical. The proposed device emits blue light, red light, yellow light and IR light.

The variance range of each wavelength of the predicate devices is ±10nm, which can cover the wavelength of the proposed device. This represents a minor difference and not one to affect equivalence. The device has passed testing according to IEC 60601-2-57. Therefore, there is no effect on safety, effectiveness, or intended use of the proposed device.

The wavelengths of the subject device can be covered by the predicate devices. The MK-90C Mode 1 and MK-90M are both the combination of 633nm and 830nm. They are consistent with the model MT-12MC, mode 2 of the predicate device 2 (K240089, 630 ± 10nm and 830nm ± 10nm).

The wavelengths of MK-90C Mode 2 and MK66RB-F are both the combination of 633nm and 415nm, which are consistent with the model MT-12MA of predicate device 2 (K240089, 415 ± 10nm and 630 ± 10nm)

The wavelengths of MK-90C Mode 3 and MK-90N are both the combination of 590nm and 830nm, the yellow light can be consistent with the model MT-12MC, mode 3 of predicate device 3 (K240089).

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

Note 3: The proposed device has similar effective irradiance with the primary predicate device (K240089) in Red, Blue, Infrared, Yellow light source and also similar in combination of Red and Infrared type and combination of Blue and Red type. For the combination of Yellow and infrared type, the proposed device is different with predicate device (K240089).

From the comparison above, the power density of the combination of Yellow and infrared type is 15+10=25mW/cm², while mode 3 of Model MT-12MC of predicate device (K240089) is 35 mW/cm², we can see the proposed devices' effective irradiance is less than secondary predicate's, so it means the proposed device will not raise safety concerns in this particular difference.

Note 4: The proposed device and predicted devices are all powered by rechargeable Lithium battery. The battery in the proposed device supports a longer battery life as well as fast charging. This does not affect the safety, effectiveness, or indications for use of the proposed device.

Comparison conclusion

The proposed device and predicate devices have the same product code, regulation number, indications for use. There are a little differences in wavelength, power density and power input / output. But these differences will not result in differences on safety and performance between

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purposed device and the predicated device.

5.Test Summary

5.1Non-Clinical Test

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC60601-1:2005+AMD1: 2012+AMD2: 2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2:2014+AMD1:2020, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility-Requirements and tests.

IEC TR 60601-4-2:2016, Medical electrical equipment- Part 4-2: Guidance and interpretation -Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.

IEC 60601-1-11:2015+AMD1:2020, 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 60601-2-57:2023,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: 2006 Photobiological safety of lamps and lamp system.

5.2Biocompatibility 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).

5.3 Light output

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

5.4 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 basic 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.

5.5 Clinical Test

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..

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6. Date of the summary prepared: February 12, 2025

7. Final Conclusion

The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K214103 and K240089.

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.