The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.

Device Description

The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is a home use wearable LED phototherapy device whose purpose is to produce an even, cool, narrow band of light for aesthetic indication for treating facial wrinkles. It emits light energy in the red and near infrared (NIR) region of the light spectrum.

The device consists of a flexible silicone mask that contains light emitting diodes (LEDs) and a controller, multi-straps, a USB-C charging cord, a pair of eye inserts and a storage bag. The LEDs generate the light. The mask is worn on the face and is held in place by the adjustable strap. The controller contains a rechargeable Lithium ion polymer battery and controls power to the mask. The controller has only one key to switch the LEDs ON/OFF and it will automatically shut down after a 10-minute treatment is completed.

AI/ML Overview

The provided FDA 510(k) clearance letter for the CurrentBody Skin™ LED Light Therapy Mask Series 2 (K250966) does not contain the detailed study information typically associated with acceptance criteria and clinical performance for an AI/ML device in the context of diagnostic performance (e.g., detecting a disease).

This device is an LED light therapy mask intended for treatment of full-face wrinkles, falling under the regulation 21 CFR 878.4810 (Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology). The primary focus of the regulatory review for such a device is safety and effectiveness based on its physical properties and intended use for cosmetic purposes, rather than diagnostic accuracy or AI-driven image analysis.

Therefore, many of the requested elements are not applicable to the information provided in this document. The document explicitly states:

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

This indicates that the device's clearance was based on demonstrating substantial equivalence to a predicate device through non-clinical tests (electrical safety, EMC, photobiological safety, battery safety, biocompatibility, and software verification/validation) and not on clinical performance metrics like sensitivity, specificity, or reader studies for diagnostic accuracy.

Addressing the Request Based on the Provided Document:

Given the nature of the device and the clearance documentation, I will answer the applicable points and explain why others are not present.

Acceptance Criteria and Device Performance for CurrentBody Skin™ LED Light Therapy Mask Series 2 (K250966)

The CurrentBody Skin™ LED Light Therapy Mask Series 2 is an LED phototherapy device for the treatment of full-face wrinkles. The acceptance criteria and performance evaluation for this device, as detailed in the 510(k) summary, are primarily focused on safety, electrical performance, material compatibility, and functional equivalence to a predicate device, rather than diagnostic performance metrics (e.g., accuracy in identifying wrinkles).

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this device is primarily based on compliance with specific international safety and performance standards, and demonstrating substantial equivalence to a predicate device for its intended use. "Device performance" is therefore reported in terms of compliance with these standards and matching key operational parameters with the predicate.

Criteria Category	Specific Acceptance Criteria (based on compliance)	Reported Device Performance
Intended Use	Treatment of full-face wrinkles (OTC).	Met: "The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles."
Device Classification	Class II, OHS Product Code.	Met: Class II, OHS.
Energy Type	Light Emitting Diodes.	Met: Uses Light Emitting Diodes.
Dose/per time	18 J/cm².	Met: 18 J/cm².
Total Intensity	30 mW/cm².	Met: 30 mW/cm².
Treatment Time	10 minutes per treatment, 5x weekly for 6 weeks.	Met: 10 minutes per treatment, 5x weekly for 6 weeks. Device automatically shuts down after 10-minute treatment.
Wavelength	Red: 630±5nm, NIR: 830nm.	Met: Red: 633nm, Infrared: 830nm. Considered compliant as slight difference (633nm vs 630±5nm) is within tolerance and does "not raise new questions of safety or effectiveness."
Electrical Safety	Compliance with IEC 60601-1, -1-2, -1-11, -2-57.	Met: "Non-clinical testing was performed on the subject device to validate the design and ensure compliance with..." these standards.
Photobiological Safety	Compliance with IEC 62471.	Met: "Non-clinical testing was performed on the subject device to validate the design and ensure compliance with..." IEC 62471.
Battery Safety	Compliance with IEC 62133-2.	Met: "The lithium battery of the subject device has been tested under standard IEC 62133-2."
Biocompatibility	Compliance with ISO 10993-1, -5, -10, -23.	Met: Demonstrated by material equivalence to previously cleared devices which were compliant with these ISO standards. No changes in formulation, processing, or sterilization of materials that would affect biocompatibility.
Software V&V	Compliance with FDA guidance.	Met: "Software verification and validation testing was performed and documentation provided in accordance with the recommendations of the Guidance for Industry and FDA Staff 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" The device uses a timer and software to control treatment duration, similar to the predicate.

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

Not applicable for performance evaluation in the context of typical AI/ML diagnostic devices. The clearance is based on non-clinical engineering and safety testing, component material equivalence, and functional equivalence to a predicate device. There is no "test set" of patient data or images in the conventional sense for evaluating diagnostic accuracy or clinical outcomes directly in this 510(k) submission.

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

Not applicable. No ground truth established by experts for a test set of clinical data, as no clinical performance study was conducted or required for this 510(k). Approval is based on safety, hardware specifications, and substantial equivalence.

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

Not applicable. No clinical test set requiring adjudication was used.

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 not a diagnostic AI device. No MRMC study was conducted or is relevant for this product's intended use (treatment of wrinkles).

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

Not applicable. This device is a hardware LED light therapy mask. While it has software for control (e.g., timer), it is not a standalone diagnostic algorithm.

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

The "ground truth" for this device's clearance is not related to clinical data or diagnostic accuracy. Instead, the "truth" is established by:

Compliance with recognized international standards for electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility.
Demonstration of substantial equivalence (same intended use, similar technological characteristics, and no new questions of safety or effectiveness) to a legally marketed predicate device (K221946).

For the purpose of treatment effectiveness validation in general, the underlying scientific basis for LED light therapy's effect on wrinkles (which is outside the scope of this specific 510k submission's clearance process details) would typically stem from clinical trials and dermatological research. However, this 510(k) relies on the predicate's established performance without new clinical studies.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data for learning or inference.

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

Not applicable. As above, no training set for an AI/ML algorithm.

In summary, the provided 510(k) clearance letter details an approval based on substantial equivalence and compliance with safety and performance standards for a hardware medical device, not on the clinical performance or diagnostic accuracy of an AI/ML driven system. Therefore, many of the requested details regarding AI/ML study methodologies are not present in this document.

Summary

FDA 510(k) Clearance Letter - CurrentBody Skin™ LED Light Therapy Mask Series 2

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov

June 25, 2025

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

Re: K250966
Trade/Device Name: CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
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
Dated: March 31, 2025
Received: March 31, 2025

Dear Dijkstra Alain:

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

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K250966 - Dijkstra Alain Page 2

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 (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

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K250966 - Dijkstra Alain Page 3

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-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: 2025.06.25 19:56:38 -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K250966

Device Name
CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H)

Indications for Use (Describe)
The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.

Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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

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

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

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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510(k) Summary: K250966

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 (CEO)
Tel: +86-135-10378748
Fax: +86-755-25024651
E-mail: alaindijkstra@kaiyanmedical.com

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

Application Correspondent:
Contact Person: Alain Dijkstra
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: registrar01@kaiyanmedical.com

2. Subject Device Information:

Trade Name: CurrentBody Skin™ LED Light Therapy Mask Series 2, Model: MK-90H
Classification Name: Light Based Over the Counter Wrinkle Reduction
Review Panel: General & Plastic Surgery
Product Code: OHS

K250966 1 / 6

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Regulation Number: 21 CFR 878.4810
Regulation Class: II

3. Predicate Device Information

Predicate Device (K221946)
Sponsor: Light Tree Ventures Europe B.V.
Trade Name: LED LIGHT THERAPY MASK
Classification Name: Light Based Over the Counter Wrinkle Reduction
Review Panel: General & Plastic Surgery
Product Code: OHS
Regulation Number: 21 CFR 878.4810
Regulation Class: II

4. Device Description

5. Intended Use / Indications for Use

The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.

6. Comparison to predicate device

Compare with the predicate device, the subject device is very similar in design principle, intended use, indications for use, functions and the applicable standards. The differences

K250966 2 / 6

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between the subject device and predicate device do not raise new questions of safety or effectiveness.

Elements of Comparison	Subject Device	Predicate Device (K221946)	Remark
Company	Shenzhen Kaiyan Medical Equipment Co., Ltd	Light Tree Ventures Europe B.V.	--
510 (K) Number	K250966	K221946	--
Device Name	CurrentBody Skin™ LED Light Therapy Mask Series 2	LED LIGHT THERAPY MASK	--
Model	MK-90H	MK66R-B	--
OTC/Rx	OTC	OTC	Same
Device Classification	Class II	Class II	Same
Product Code	OHS	OHS	Same
Regulation Number	21 CFR 878.4810	21 CFR 878.4810	Same
Indications for Use / Intended use	The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.	The LED LIGHT THERAPY MASK (MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.	Same
Intended Area of Use	Face	Face	Same
Power Source	Rechargeable Lithium battery: 3.7V, 2600mAh, 9.62Wh	Rechargeable Lithium battery	Same (Note 1)
Energy Type	Light emitting diodes	Light emitting diodes	Same
Type	Mask	Mask	Same
Dose/per time(J/cm²)	18	18	Same
LED Wavelength	Red: 633nm Infrared: 830nm	Red:630±5nm NIR:830nm	Similar (Note 2)

K250966 3 / 6

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Elements of Comparison	Subject Device	Predicate Device (K221946)	Remark
LED Number	633nm:110 830nm:110	630±5nm:66 830nm:66	Different (Note 2)
Total Intensity (mW/cm²)	30 mW/cm²	30 mW/cm²	Same
Treatment Time	10 minutes per treatment 5 times weekly for 6 weeks	10 minutes per treatment 5 x weekly, 6weeks	Same
Software controller	Device uses a timer and software to control treatment duration	Device uses a timer and software to control treatment duration	Same
Electrical Safety	Compliant with IEC 60601- 1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57 IEC 62471	Compliant with IEC 60601- 1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57 IEC 62471	Same
Biocompatibility	ISO 10993-1 ISO10993-5 ISO10993-10 ISO10993-23	ISO 10993-1 ISO10993-5 ISO10993-10 ISO10993-23	Same

Comparison in Detail(s):

Note 1:
The power supply for the subject device is the same as that of the predicate device and the lithium battery of the subject device has been tested under standard IEC 62133-2.

Note 2:
The wavelengths of subject device (633nm and 830nm) are slightly different, but are within the wavelength tolerance of the predicate devices (630nm±5nm, 830nm). The LED number of subject device is a little different from that of the predicate device, but the wavelengths, total intensity, treatment time and dose are the same for both and comply with the requirements of

K250966 4 / 6

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IEC60601-1, IEC60601-1-2, IEC60601-2-57 and IEC62471 safety standards. Therefore, these minor differences do not raise any safety or effectiveness issues.

7. Test Summary

7.1 Non-Clinical Tests Performed

1) Electrical Safety, and Electromagnetic Compatibility Test

Non-clinical testing was performed on the subject device to validate the design and ensure compliance with the following standards related to medical device electrical safety, electromagnetic compatibility, photobiological safety and battery safety:

IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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 2.0 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 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 TS 60601-4-2:2024 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems.
IEC 62133-2:2017+AMD1:2021 Edition1.1 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 component materials (mask inner shell and outer shell) of the subject device are identical in formulation, processing and sterilization to the corresponding component materials (mask inner shell and outer shell) of the previously cleared devices (K221444, LED Eye Perfector, Model:

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EY-36A) and no other chemicals added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents). The eye protections of the subject device are identical in formulation, processing, sterilization, and geometry to the eye protection of the previously cleared device (K242593, CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask, model: MK-90C) and no other chemicals added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents). Also there is no change in biocompatibility since the previously cleared devices. Therefore, based on this information, the subject device can comply with the biocompatibility requirements of 1S0 10993-5 (cytotoxicity), ISO 10993-10 (sensitization) and lSO 10993-23 (irritation).

3) Software Verification and Validation

Software verification and validation testing was performed and documentation provided in accordance with the recommendations of the Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

7.2 Summary of Clinical Performance

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

8. Date of the summary prepared: June 23, 2025

9. Final Conclusion

The subject device is as safe, as effective, and performs as well as the legally marketed predicate device K221946.

K250966 6 / 6

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.