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

K230336 · Light Tree Ventures Europe B.V. · OAP · Apr 5, 2023 · Physical Medicine

Device Facts

• Record ID: K230336
• Device Name: CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
• Applicant: Light Tree Ventures Europe B.V.
• Product Code: OAP · Physical Medicine
• Decision Date: Apr 5, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

Over-the-counter LED hair regrowth cap; treats Androgenetic Alopecia via photostimulation. Device inputs: electrical power from lithium battery. Operation: user wears cap on head; emits visible red light at 660nm via 120 LEDs; uniform light distribution across scalp. Output: 10-minute automated treatment session; device shuts off automatically. Used in home environment by patient. Healthcare provider reviews clinical history to determine suitability; device output (light exposure) intended to stimulate hair follicles. Benefits: non-invasive hair growth promotion.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, including electrical safety (IEC 60601-1, 60601-1-11, 60601-2-57), electromagnetic compatibility (IEC 60601-1-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993-5, 10993-10).

Technological Characteristics

Infrared lamp (21 CFR 890.5500). Materials: PC+ABS (outer shell), Silicone (inner shell). 120 visible red LEDs (660nm). Power: lithium battery. Irradiance: 1.67 mW/cm²; Fluence: 1 J/cm². Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62471, IEC 62133-2, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for males (Norwood-Hamilton IIa-V) and females (Ludwig-Savin I-1 to I-4, II-1, II-2, or frontal patterns) with Androgenetic Alopecia and Fitzpatrick Skin Types I-IV to promote hair growth.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Revian Red (K173729)

Reference Devices

• LED Eye Perfector (K221444)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|---------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> |

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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: [phone] Fax: [phone] E-mail: [e-mail]

#### 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: [phone] Email: [e-mail]

## 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, 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.

#### 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 of<br>Comparison | Subject Device | Predicate Device | Verdict |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Company | Light Tree Ventures Europe<br>B.V. | PhotonMD, Inc. | -- |
| Trade Name | CurrentBody Skin™ LED Hair<br>Regrowth | 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 of<br>Comparison | Subject Device | Predicate Device | Verdict |
| Intended Use /<br>Indications for Use | The LED Hair Regrowth(MZ-<br>07) is indicated to treat<br>Androgenetic Alopecia and to<br>Promote Hair Growth in males<br>who have Norwood-Hamilton<br>Classifications of Ila - V<br>patterns of hair loss and to<br>treat Androgenetic Alopecia<br>and Promote Hair Growth in<br>females who have Ludwig-<br>Savin Scale I-1 to I-4, II -1, II-2<br>or frontal patterns of hair loss;<br>both with Fitzpatrick Skin<br>Types I - IV. | The REVIAN RED device is<br>indicated to treat<br>Androgenetic Alopecia and to<br>Promote Hair Growth in males<br>who have Norwood-Hamilton<br>Classifications of Ila - V<br>patterns of hair loss and to<br>treat Androgenetic Alopecia<br>and Promote Hair Growth in<br>females who have Ludwig-<br>Savin Scale I-1 to I-4, II -1, II-<br>2 or frontal patterns of hair<br>loss; both with Fitzpatrick Skin<br>Types I - IV. | Same |
| Location for use | OTC | OTC | Same |
| Intended User | Females & Males | Females & Males | Same |
| Type of light | Visible red light-emitting<br>diodes | Visible red light-emitting<br>diodes | Same |
| Wavelength | 660 nm | 620-660 nm | Similar<br>Note1 |
| Amount of diodes | 120 | 119 | Similar<br>Note 2 |
| Power Supply | lithium battery | lithium polymer | Same |
| Irradiance | 1.67 mw/cm² | Not available | Different<br>Note 3 |
| Fluence | 1 J/cm² | Not available | Different<br>Note 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,<br>IEC 60601-1-2, IEC 60601-1-<br>11, IEC 60601-2-57, IEC<br>62471, IEC 62133-2 | Complied with IEC 60601-1,<br>IEC 60601-1-2, IEC 60601-1-<br>11, IEC 62471 | Same |
| Biocompatibility | All patient contacting materials<br>are complied with ISO 10993-<br>5, ISO 10993-10 | All patient contacting<br>materials are comply with ISO<br>10993-5, 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 | Device<br>Description/Sample<br>Size | Test<br>Method/Applicable<br>Standards | Acceptance<br>criteria | Unexpected<br>Results/<br>Significant<br>Deviations | Test<br>results |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------|
| General<br>requirements<br>for basic safety<br>and essential<br>performance | The test<br>sample is<br>the final,<br>finished<br>product. | 2005/(R)20<br>12 &<br>A1:2012,<br>C1:2009/(R<br>)2012 &<br>A2:2010/(R)<br>2012<br>(Cons.<br>Text) [Incl.<br>AMD2:2021<br>] | The test is<br>carried out<br>under the test<br>method<br>specified in the<br>standard, and<br>the test result<br>is within the<br>test<br>acceptance<br>range of the<br>standard. | NA | Pass |
| Electromagnetic<br>c disturbances | The test<br>sample is<br>the final,<br>finished<br>product. | IEC 60601-<br>1-2:2020 | No degradation<br>of performance<br>was found<br>during test or<br>Lower than<br>limits of<br>measurement. | NA | Pass |
| Requirements<br>for medical<br>electrical<br>equipment and<br>medical<br>electrical<br>systems used | The test<br>sample is<br>the final,<br>finished<br>product. | IEC 60601-<br>1-11: 2020 | The device<br>operates<br>normally, and<br>can provide<br>basic safety<br>and essential<br>performance | NA | Pass |

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| in the home<br>healthcare<br>environment | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|------|
| Particular<br>Requirements<br>for The Basic<br>Safety And<br>Essential<br>Performance Of<br>Non-Laser Light<br>Source<br>Equipment<br>Intended For<br>Therapeutic,<br>Diagnostic,<br>Monitoring And<br>Cosmetic/Aesth<br>etic Use | The test<br>sample is<br>the final,<br>finished<br>product. | IEC 60601-<br>2-57:2011 | The test is<br>carried out<br>under the test<br>method<br>specified in the<br>standard, and<br>the test result<br>is within the<br>test<br>acceptance<br>range of the<br>standard. | NA | Pass |
| Photobiological<br>safety of lamps<br>and lamp<br>systems. | The test<br>sample is<br>the final,<br>finished<br>product. | IEC<br>62471:2006 | The test is<br>carried out<br>under the test<br>method<br>specified in the<br>standard, and<br>the test result<br>is within the<br>test<br>acceptance<br>range of the<br>standard. | NA | Pass |

### 2)

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

| Components of<br>Subject Device | Material of<br>Components | Body Contact<br>Category<br>(ISO 10993-1) | Contact Duration<br>(ISO 10993-1) |
|---------------------------------|---------------------------|-------------------------------------------|-----------------------------------|
| Shell (Outer surfaces) | PC+ABS | Surface-contacting<br>device: skin | ≤30 mins |
| Shell (Inner surface) | Silicone | Surface-contacting<br>device: 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.