CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION June 17, 2025 Shenzhen Kaiyan Medical Equipment Co., Ltd Alain Dijkstra CEO Building#3 and Building#5, 40th of Fuxin Street Huaide Community Fuyong Town Baoan District Shenzhen, Guangdong 518103 China Re: K251017 Trade/Device Name: CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: March 31, 2025 Received: April 2, 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/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. U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251017 - Alain Dijkstra Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. {2} K251017 - Alain Dijkstra Page 3 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: 2025.06.17 15:35:14 -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 {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | 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) K251017 | | | Device Name CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | | | Indications for Use (Describe) The CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with who have Norwood-Hamilton classifications of IIa-V or females with who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV. | | | 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." | | {4} Page 1 of 8 K251017 - 510(k) Summary 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: 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 Tel: 0755-82129361 Fax: 0755-25024651 Contact Person (including title): Alain Dijkstra (CEO) E-mail: regulation@kaiyanmedical.com Distributor Company Name: CurrentBody.com Ltd Address: Q17, Crossley Road, Stockport, Greater Manchester, SK4 5BB United Kingdom Application Correspondent: Contact Person: Mr. 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: regulation@kaiyanmedical.com 2. Summary Prepared Date 23 May 2025 3. Subject Device Information Trade Name: CurrentBody Skin Dual Light Hair Growth Helmet Model: MZ-07A Common Name: Laser, Comb, Hair Classification Name: Infrared Lamp Review Panel: General &amp; Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II 4. Predicate Device Information {5} Page 2 of 8 # Primary Predicate Device Information Sponsor: Nature Incredible Inc. Trade Name: Neuhat Hair Growth System (or ibeauty.com Laser Cap) Model: NEU300, NEU180 510(k) Number: K231153 Review Panel: General &amp; Plastic Surgery Regulatory Class: Class II Regulatory Code: OAP Regulation: 21 CFR 890.5500 # Reference device Sponsor: Ronald E. Berglund, GRACE Consulting, LLC Trade Name: Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap Model: 128 model, 162 model, 288 model 510(k) Number: K240456 Review Panel: General &amp; Plastic Surgery Regulatory Class: Class II Regulatory Code: OAP Regulation: 21 CFR 890.5500 # 5. Device Description The CurrentBody Skin Dual Light Hair Growth Helmet (model:MZ-07A) is an over-the-counter device designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to promote hair growth in females who have Ludwig-Savin Classifications of I-II; both with Fitzpatrick Skin Types I-IV. The device consists of 100 laser diodes with wavelength at $655 \pm 5\mathrm{nm}$, and 200 red light diodes with wavelength at $660 \pm 5\mathrm{nm}$. The CurrentBody Skin Dual Light Hair Growth Helmet includes a hair-growing cap, a device base and a USB power cord. There are LEDs and lasers diodes inside the cap to emit visible red light, the device base acts as a support when the device is not used. There is a power button on cap to turn on/off the device, a digital display to show the remaining treatment time, an power indicator to show charging status and a USB port for charging. The treatment parameter is pre-set by manufacturer, the device will auto off after treatment. # 6. Intended Use {6} The CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with who have Norwood-Hamilton classifications of IIa-V or females with who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV. ## 7. Comparison to Predicate Device 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 of Comparison | Subject Device | Primary predicate | Reference device | Verdict | | --- | --- | --- | --- | --- | | Company | Shenzhen Kaiyan Medical Equipment Co., Ltd | Nature Incredible Inc. | Ronald E. Berglund, GRACE Consulting, LLC | -- | | Trade Name | CurrentBody Skin Dual Light Hair Growth Helmet | Neuhat Hair Growth System (or ibeauty.com Laser Cap) | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap | -- | | 510(k) Number | Applying | K231153 | K240456 | -- | | Regulation number | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | Same | | Classification Name | Infrared Lamp | Infrared Lamp | Infrared Lamp | Same | | Product Code | OAP | OAP | OAP | Same | | Class | II | II | II | Same | {7} | Elements of Comparison | Subject Device | Primary predicate | Reference device | Verdict | | --- | --- | --- | --- | --- | | Intended Use / Indications for Use | The CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa~V or females with androgenic alopecia who have Ludwig-Savin Classifications of I~II and both with Fitzpatrick Skin Phototypes I to IV. | Neuhat Hiar Growth System is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with addrogneic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV. ibeauty.com Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with addrogneic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV. | Indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II and Fitzpatrick Classification of Skin Phototypes I to IV. | Same | | Location for use | OTC | OTC | OTC | Same | | Intended User | Both sex | Both sex | Both sex | Same | | Type of light | Low-level laser diodes and light emitting diodes | Low-level laser diodes and light emitting diodes | Low-level laser diodes and light-emitting diodes | Same | | Wavelength | Laser: 655 ±5nm LED: 660 ± 5nm | Laser: 655nm Red light LED: 650nm | 650nm | Similar Note1 | | Number of diodes | Laser diodes: 100 LED diodes: 200 | NEU300 Laser diodes: 100 LED diodes: 200 NEU180 Laser diodes: 50 LED diodes: 130 | 288 model: 115 LDs, 173 LEDs | Same | Page 4 of 8 {8} | Elements of Comparison | Subject Device | Primary predicate | Reference device | Verdict | | --- | --- | --- | --- | --- | | Energy of per laser diode | 5 mw | 5mw | 5mW per light | Same | | Distribution | Uniform | Not public available | Uniform | Same | | Treatment Time | Every day 20 mins | Each treatment: 25 mins Total Treatment: 16 weeks, every other day (indefinite) | 25 minutes every day | Same Note 2 | | Irradiance | 2.85 mw/cm² | Not public available | 2.47 mw/cm² | Same Note 2 | | Applicable people | Norwood-Hamilton IIa~V (males); Ludwig-Savin I~II (females) | Norwood-Hamilton IIa~V (males); Ludwig-Savin I~II (females) | Norwood-Hamilton IIa~V (males); Ludwig-Savin I~II (females) | Same | | Applicable skin | Fitzpatrick Skin Phototypes I-IV | Fitzpatrick Skin Phototypes I-IV | Fitzpatrick Skin Phototypes I-IV | Same | | Helmet/Cap design | Yes | Yes | Yes | Same | | Biocompatibility feature | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | Not public available | Same | Comparison in Detail(s): Note 1: Though the wavelength of subject device is a little different from predicate devices, it is very close to predicate devices. Therefore, this slight difference will not raise any effectiveness or safety issue. Note 2: The treatment time and irradiance of the subject device are a little difference from the predicate devices but very close. Therefore, this slight difference will not raise any effectiveness or safety issue. 8. Test Summary 7.1 Summary of Non-Clinical Performance Testing 1) Performance Testing Summary The CurrentBody Skin Dual Light Hair Growth Helmet (Model: MZ-07A) has been evaluated the safety and performance by lab bench testing as following: {9} | Standards No. | Standard Title | Version | Recognition Number | | --- | --- | --- | --- | | IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Edition 3.2 2020-08 | 19-49 | | IEC 60601-1-11 | 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 | Edition 2.1 2020-07 | 19-38 | | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | Edition 4.1 2020-09 | 19-36 | | IEC TS 60601-4-2 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems | IEC TS 60601-4-2: Edition 1.0 2024-03 | 19-50 | | IEC 60601-2-57 | 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 | Edition 2.0 2023-07 | 12-355 | | IEC 60825-1 | Safety of laser products - Part 1: Equipment classification and requirements [Including: Technical Corrigendum 1 (2008) Interpretation Sheet 1 (2007) Interpretation Sheet 2 (2007)] | Edition 2.0 2007-03 | 12-273 | Page 6 of 8 {10} Page 7 of 8 | Standards No. | Standard Title | Version | Recognition Number | | --- | --- | --- | --- | | IEC 62471 | Photobiological safety of lamps and lamp systems | First edition 2006-07 | 12-249 | | IEC 62133-2 | 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 | Edition 1.0 2017-02 | 19-33 | ## 2) Biocompatibility The patient directly contracting materials in the subject device are showed in the following list. | Components of Subject Device | Material of Components | Body Contact Category (ISO 10993-1) | Contact Duration (ISO 10993-1) | | --- | --- | --- | --- | | Inner surface of cap | Silicone | Surface-contacting device: skin | A-limited(<24h) | The Nature of body contact is Surface medical device-Intact 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 The inner surface of cap (silicone) is identical to cleared device K230336 in formulation, processing, and cleaning, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents. Etc.). ## 3) 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. ## 4) 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. {11} Page 8 of 8 ## 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 device K231153 and K240456.