The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

Device Description

The CurrentBody Skin™ Led Hair Regrowth, model: MZ-07 is an over-the-counter light-emitting diode (LED) device designed to promote hair growth in women and men by exposing the entire scalp to the photostimulation of visible red light-emitting diodes at 660nm. The CurrentBody Skin™ Led Hair Regrowth includes a hair-growing cap, a device base and a USB power cord. The user turns on the device and then wears the device on his/her head, and the device will turn off automatically after a 10-minute treatment default.

AI/ML Overview

The provided text does not describe a study that proves the device meets specific acceptance criteria related to its clinical efficacy (i.e., hair regrowth performance) with quantitative metrics for artificial intelligence (AI) performance. Instead, it refers to a 510(k) premarket notification for a medical device (CurrentBody Skin™ Led Hair Regrowth) which is largely relying on substantial equivalence to a predicate device (Revian Red).

The "acceptance criteria" and "device performance" mentioned in the document primarily relate to non-clinical performance testing (e.g., electrical safety, electromagnetic compatibility, biocompatibility, software validation), rather than clinical outcomes or AI performance. The document explicitly states: "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."

Therefore, I cannot directly fulfill all aspects of your request as it pertains to a study proving the device meets AI performance acceptance criteria or clinical efficacy data with AI assistance. However, I can provide the information available in the text regarding the non-clinical acceptance criteria and testing.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Acceptance Criteria	Reported Device Performance
General requirements for basic safety and essential performance (IEC 60601-1): Test result is within the test acceptance range of the standard.	Pass
Electromagnetic disturbances (IEC 60601-1-2): No degradation of performance was found during test or Lower than limits of measurement.	Pass
Requirements for medical electrical equipment and systems used in the home healthcare environment (IEC 60601-1-11): The device operates normally, and can provide basic safety and essential performance.	Pass
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 60601-2-57): Test result is within the test acceptance range of the standard.	Pass
Photobiological safety of lamps and lamp systems (IEC 62471): Test result is within the test acceptance range of the standard.	**Pass
Biocompatibility (ISO 10993-5, ISO 10993-10 for Cytotoxicity, Irritation/Intracutaneous reactivity, Sensitization): All patient contacting materials are complied with these standards. (Note: This is stated as compliance with standards rather than specific test results being presented in the table).	Pass (Implied by "complied with")
Usability (IEC 62366-1 and IEC 60601-1-6): The device complies with these standards.	Complies
Software verification and validation: Software considered "moderate" level concern, V&V testing conducted and documentation provided. (Acceptance criteria not explicitly quantified, but compliance with FDA guidance is implied).	Conducted (Implied as sufficient for "moderate" concern)
Cybersecurity: No external interfaces, no need for cybersecurity evaluation per FDA guidance.	N/A (No evaluation needed)

Notes on Clinical Efficacy / AI Performance:

This document is a 510(k) summary, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new major clinical trials for efficacy.
The device (CurrentBody Skin™ Led Hair Regrowth) is a light-emitting diode (LED) device, not an AI software. The request itself is framed around AI performance, but the document describes a hardware device.

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

Non-Clinical Testing: For most tests (General safety, EMC, Home healthcare, Particular requirements for light source equipment, Photobiological safety), the "Device Description/Sample Size" is stated as "The test sample is the final, finished product." This generally implies a very small sample size, often one or a few units, for regulatory compliance testing.
Biocompatibility: The document states "All patient contacting materials are complied with ISO 10993-5, ISO 10993-10," citing prior clearance (K221444) for identical materials used in another device. This means the actual biocompatibility testing was likely performed for the predicate or a previously cleared device.
Data Provenance: Not specified beyond standard lab bench testing for regulatory compliance. It's not clinical data.

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

Not applicable. This is a hardware device undergoing non-clinical safety and performance testing for regulatory submission (510(k)). There is no "ground truth" derived from expert consensus for clinical outcomes or AI performance, as no clinical efficacy study or AI component is described as being part of the evaluation for this submission.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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

No. An MRMC study is typically performed for imaging diagnostic AI devices to compare human reader performance with and without AI assistance. This document describes a therapeutic LED device, not a diagnostic AI. The document explicitly states: "Clinical testing was not needed for this 510(k)."

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

Not applicable. The device is a physical LED hair regrowth cap, not an algorithm.

7. The Type of Ground Truth Used

Not applicable for clinical efficacy or AI performance. For the non-clinical tests, the "ground truth" is defined by the requirements and performance limits specified in the referenced international standards (e.g., IEC 60601 series, IEC 62471, ISO 10993 series).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. See point 8.

In summary, the provided document focuses on the regulatory clearance process for a physical medical device (LED hair regrowth cap) based on substantial equivalence and compliance with non-clinical safety and performance standards. It does not contain information about studies involving AI, human reader performance, or detailed clinical efficacy trials with quantifiable acceptance criteria for hair regrowth.

Summary

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April 5, 2023

Light Tree Ventures Europe B.V. Alain Dijkstra Manager Laan van Ypenburg 108, 2497 GC Hague. Netherlands

Re: K230336

Trade/Device Name: CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: January 18, 2023 Received: February 7, 2023

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 (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 located 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.

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

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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).

Sincerelv.

Colin K. Chen -S

for

Jianting Wang Acting 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) K230336

Device Name

CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07)

Indications for Use (Describe)

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)

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510(k) Summary for K230336

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

1. Submitter Information

Sponsor Name: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Contact name: Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: regulation@kaiyanmedical.com

Manufacture

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

Distributor

Company Name: CurrentBody.com Ltd

Address: Unit D6, Stanley Green Business Park, Commercial Avenue, Cheadle Hulme, Cheshire, SK8 6QH

Application Correspondent:

Contact Person: Alain Dijkstra Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Tel: +86-135-10378748 Email: requlation@kaiyanmedical.com

2. Summary Prepared Date

29 March 2023

3. Subject Device Information

Trade Name: CurrentBody Skin™ Led Hair Regrowth

Model: MZ-07

Common Name: Laser, Comb, Hair

Classification Name: Infrared Lamp

Review Panel: General & Plastic Surgery

Product Code: OAP

Regulation Number: 21 CFR 890.5500

Regulation Class: II

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4. Predicate Device Information

Sponsor: PhotonMD, Inc. Common Name: Laser, Comb, Hair Classification Name: Infrared Lamp Trade Name: Revian Red 510(K) Number: K173729 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II

5. Device Description

The CurrentBody Skin™ Led Hair Regrowth includes a hair-growing cap, a device base and a USB power cord. The user turns on the device and then wears the device on his/her head, and the device will turn off automatically after a 10-minute treatment default.

Intended Use 6.

The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

Comparison to Predicate Device 7.

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

Elements ofComparison	Subject Device	Predicate Device	Verdict
Company	Light Tree Ventures EuropeB.V.	PhotonMD, Inc.	--
Trade Name	CurrentBody Skin™ LED HairRegrowth	Revian Red	--
510(k) Number	K230336	K173729	--
Regulation number	21 CFR 890.5500	21 CFR 890.5500	Same
Classification Name	Infrared Lamp	Infrared Lamp	Same
Product Code	OAP	OAP	Same
Class	II	II	Same
Elements ofComparison	Subject Device	Predicate Device	Verdict
Intended Use /Indications for Use	The LED Hair Regrowth(MZ-07) is indicated to treatAndrogenetic Alopecia and toPromote Hair Growth in maleswho have Norwood-HamiltonClassifications of Ila - Vpatterns of hair loss and totreat Androgenetic Alopeciaand Promote Hair Growth infemales who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2or frontal patterns of hair loss;both with Fitzpatrick SkinTypes I - IV.	The REVIAN RED device isindicated to treatAndrogenetic Alopecia and toPromote Hair Growth in maleswho have Norwood-HamiltonClassifications of Ila - Vpatterns of hair loss and totreat Androgenetic Alopeciaand Promote Hair Growth infemales who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hairloss; both with Fitzpatrick SkinTypes I - IV.	Same
Location for use	OTC	OTC	Same
Intended User	Females & Males	Females & Males	Same
Type of light	Visible red light-emittingdiodes	Visible red light-emittingdiodes	Same
Wavelength	660 nm	620-660 nm	SimilarNote1
Amount of diodes	120	119	SimilarNote 2
Power Supply	lithium battery	lithium polymer	Same
Irradiance	1.67 mw/cm²	Not available	DifferentNote 3
Fluence	1 J/cm²	Not available	DifferentNote 3
Distribution	Uniform distribution	Uniform distribution	Same
Treatment Time	Every day 10 mins	Every day 10 mins	Same
Helmet/Cap design	Yes	Yes	Same
Safety	Complied with IEC 60601-1,IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC62471, IEC 62133-2	Complied with IEC 60601-1,IEC 60601-1-2, IEC 60601-1-11, IEC 62471	Same
Biocompatibility	All patient contacting materialsare complied with ISO 10993-5, ISO 10993-10	All patient contactingmaterials are comply with ISO10993-5, ISO 10993-10	Same

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Comparison in Detail(s):

Note 1:

Although the "Wavelength" of the subject device is slightly different from the predicate device, the wavelength of the subject device is included in the wavelength range of the predicate device. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.

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Note 2:

Although the "Amount of diodes" of the subject device is slightly different from the predicate device, specifications between them is different and the overall fluence is similar. So, the slightly difference between the subject device and the predicate device will not raise any safety or effectiveness issues.

Note 3:

Although there is no publicly available of the "irradiance" and the "fluence" for the predicate device, the subject device has the same / similar treatment parameters in "wavelength", "amount of diodes", "distribution" and "treatment time" with the predicate device. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.

8. Test Summary

7.1 Summary of Non-Clinical Performance Testing

Performance Testing Summary 1)

The CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07) has been evaluated the safety and performance by lab bench testing as following:

Title of the test	DeviceDescription/SampleSize	TestMethod/ApplicableStandards	Acceptancecriteria	UnexpectedResults/SignificantDeviations	Testresults
Generalrequirementsfor basic safetyand essentialperformance	The testsample isthe final,finishedproduct.	2005/(R)2012 &A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012(Cons.Text) [Incl.AMD2:2021]	The test iscarried outunder the testmethodspecified in thestandard, andthe test resultis within thetestacceptancerange of thestandard.	NA	Pass
Electromagneticc disturbances	The testsample isthe final,finishedproduct.	IEC 60601-1-2:2020	No degradationof performancewas foundduring test orLower thanlimits ofmeasurement.	NA	Pass
Requirementsfor medicalelectricalequipment andmedicalelectricalsystems used	The testsample isthe final,finishedproduct.	IEC 60601-1-11: 2020	The deviceoperatesnormally, andcan providebasic safetyand essentialperformance	NA	Pass

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in the homehealthcareenvironment
ParticularRequirementsfor The BasicSafety AndEssentialPerformance OfNon-Laser LightSourceEquipmentIntended ForTherapeutic,Diagnostic,Monitoring AndCosmetic/Aesthetic Use	The testsample isthe final,finishedproduct.	IEC 60601-2-57:2011	The test iscarried outunder the testmethodspecified in thestandard, andthe test resultis within thetestacceptancerange of thestandard.	NA	Pass
Photobiologicalsafety of lampsand lampsystems.	The testsample isthe final,finishedproduct.	IEC62471:2006	The test iscarried outunder the testmethodspecified in thestandard, andthe test resultis within thetestacceptancerange of thestandard.	NA	Pass

2)

The patient directly contracting materials in the subject device are showed in the following list.

Components ofSubject Device	Material ofComponents	Body ContactCategory(ISO 10993-1)	Contact Duration(ISO 10993-1)
Shell (Outer surfaces)	PC+ABS	Surface-contactingdevice: skin	≤30 mins
Shell (Inner surface)	Silicone	Surface-contactingdevice: skin	≤30 mins

The Nature of body contact is scalp, skin contact. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:

Cytotoxicity
Irritation or intracutaneous reactivity .
. Sensitization

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The component materials for Shell (Outer surfaces and inner surface) of the CurrentBody Skin™ Led Hair Regrowth (Models: MZ-07) is identical to the corresponding component for Shell (Outer surfaces and inner surface ) of the LED Eye Perfector (Model: EY-36A) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents), that manufactured by Light Tree Ventures Europe B.V. and has been cleared in K221444 on December 08, 2022.

3) Usability Testing

Usability testing was conducted on the CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07), the device complies with IEC 62366-1 and IEC 60601-1-6.

4) Software verification and validation testing

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.

5) Cybersecurity

The subject device no any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", no need cybersecurity evaluation.

7.2 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.

9. Conclusion

The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K173729.

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.