Neuhat Hair Growth System; ibeauty.com Laser Cap

K231153 · Nature, Inc.redible, Inc. · OAP · Jun 23, 2023 · Physical Medicine

Device Facts

• Record ID: K231153
• Device Name: Neuhat Hair Growth System; ibeauty.com Laser Cap
• Applicant: Nature, Inc.redible, Inc.
• Product Code: OAP · Physical Medicine
• Decision Date: Jun 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Neuhat Hair Growth System is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic 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 androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.

Device Story

Device is a wearable laser cap (models NEU180, NEU300) for home-use hair growth promotion. System utilizes low-level laser diodes (655nm) and red light LEDs (650nm) to deliver therapeutic light to the scalp. Device consists of outer plastic cover, protective inner liner, and power adapter. User wears cap for 25-minute sessions, every other day, for 16 weeks. Principle of operation relies on photobiomodulation to stimulate hair follicles. Output is non-ionizing light energy. Device is intended for OTC use by patients to potentially increase hair density and growth.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by biocompatibility testing (ISO 10993-5, ISO 10993-10) and electrical/photobiological safety testing (IEC 60601 series, IEC 62471, IEC 60825-1).

Technological Characteristics

Wearable cap design; laser diodes (655nm) and red light LEDs (650nm); power ≤5mW per diode. Materials comply with ISO 10993-5 and ISO 10993-10. Powered by external adapter. Tested to IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-57, 60825-1, and 62471.

Indications for Use

Indicated for males with androgenic alopecia (Norwood-Hamilton IIa-V) and females with androgenic alopecia (Ludwig-Savin I-II) with Fitzpatrick Skin Phototypes 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

• Hair Growth Device (K210169)

Reference Devices

• LG Pra.L Derma LD Scalp Care (K200464)

Submission Summary (Full Text)

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

June 23, 2023

Nature Incredible Inc John Lee General Manager 3422 Old Capitol Trail #569 Wilmington, Delaware 19808

Re: K231153

Trade/Device Name: Neuhat Hair Growth System; ibeauty.com Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: April 24, 2023 Received: April 24, 2023

Dear John Lee:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 (OS) 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).

Sincerely,

# Jianting Wang -S

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) K231153

Device Name Neuhat Hair Growth System ibeauty.com Laser Cap

#### Indications for Use (Describe)

Neuhat Hair Growth System is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic 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 Ila-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.

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

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## 510(k) Summary K231153

"510(k) Summary" as required by 21 CFR Part 807.92.

## Date: 2023-06-22

## 1. Submitter

Nature Incredible Inc. 3422 OLD CAPITOL TRAIL #569 WILMINGTON, DELAWARE 19808 Tel.: [phone]

John Lee (General Manager) Tel: [phone] Email: [e-mail]

## 2. Device

Type of 510(k): Traditional Common Name: Lamp, non-heating, for promotion of hair growth Trade Name: Neuhat Hair Growth System (or ibeauty.com Laser Cap) Model: NEU180, NEU300 Regulation Name: Review Panel: General & Plastic Surgery Regulatory Class: II Product Code: OAP Regulation Number: 21 CFR 890.5500

## 3. Predicate Device

| Applicant | Primary Predicate<br>Device | Reference device |
|-------------------|------------------------------|---------------------------------|
| 510(k) Number | K210169 | K200464 |
| Trade name | Hair Growth Device | LG Pra.L Derma LD<br>Scalp Care |
| Model | LS-D601 | / |
| Regulation name | Infrared Lamp | Infrared Lamp |
| Review Panel | General & Plastic<br>Surgery | General & Plastic<br>Surgery |
| Regulation Class | Class II | Class II |
| Regulation number | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Product code | OAP | OAP |

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#### Device Description 4.

The System includes NEU180 and NEU300 two models.

NEU180 consists of 50 laser diodes with wavelength at 655mm, power ≤5mW, and 130 red light diodes with wavelength at 650 nm, power ≤5mW.

NEU300 consists of 100 laser diodes with wavelength at 655nm, power ≤5mW, and 200 red light diodes with wavelength at 650 nm, power ≤5mW.

The System is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an adapter.

#### Indications for Use 5.

Neuhat Hair Growth System is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V and females with androgenic 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 androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.

#### 6. Comparison of Technological Characteristics With the Predicate Device

Neuhat Hair Growth System (or ibeauty.com Laser Cap) raises no safety or efficacy concerns as compared to the predicate devices.

| Comparison<br>Elements | Subject Device | Primary Predicate<br>Device | Reference device I | Remark |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| K Number | Pending | K210169 | K200464 | / |
| Trade name | Neuhat Hair Growth<br>System (or<br>ibeauty.com Laser<br>Cap) | Hair Growth Device | LG Pra. L Derma LD<br>Scalp Care | / |
| Model | NEU300, NEU180 | LS-D601 | / | / |
| Classification<br>name | Infrared Lamp | Infrared Lamp | Infrared Lamp | Same |
| Product code | OAP | OAP | OAP | Same |
| Comparison<br>Elements | Subject Device | Primary Predicate<br>Device | Reference device I | Remark |
| Intended<br>use/Indications<br>for Use | Neuhat Hair Growth<br>System is indicated<br>to promote hair<br>growth in males with<br>androgenic alopecia<br>who have Norwood-<br>Hamilton<br>classifications of IIa-<br>V and females with<br>androgenic alopecia<br>who have Ludwig-<br>Savin Classifications<br>of I-II and Fitzpatrick<br>Classification of Skin<br>Phototypes I-IV.<br>ibeauty.com Laser<br>Cap is indicated to<br>promote hair growth<br>in males with<br>androgenic alopecia<br>who have Norwood-<br>Hamilton<br>classifications of IIa-<br>V and females with<br>androgenic alopecia<br>who have Ludwig-<br>Savin Classifications<br>of I-II and Fitzpatrick<br>Classification of Skin<br>Phototypes I-IV. | The Hair Growth<br>Device is indicated to<br>promote hair growth<br>in males with<br>androgenetic alopecia<br>who have Hamilton-<br>Norwood<br>Classifications of Ila-<br>V and females with<br>androgenetic alopecia<br>who have Ludwig-<br>Savin Classifications<br>of I-II and Fitzpatrick<br>Classification of Skin<br>Phototypes I to IV. | The LG Pra.L Derma LD<br>Scalp Care is indicated<br>to promote hair growth<br>in males with<br>androgenetic alopecia<br>who have Hamilton-<br>Norwood Classifications<br>of IIa-V and females<br>with androgenetic<br>alopecia who have<br>Ludwig-Savin<br>Classifications of I-II<br>and Fitzpatrick<br>Classification of Skin<br>Phototypes I to IV. | Same |
| Intended user | Both sex | Both sex | Both sex | Same |
| Location for use | OTC application | OTC application | OTC application | Same |
| Type of Light | Low-level laser<br>diodes and light<br>emitting diodes | Low-level laser diodes<br>and light emitting<br>diodes | Low-level laser diodes<br>and light emitting diodes | Same |
| Comparison<br>Elements | Subject Device | Primary Predicate<br>Device | Reference device I | Remark |
| Wavelength | Laser: 655nm<br>Red light LED:<br>650nm | Laser: 650-660nm<br>Red light LED: 640-<br>660nm | Laser: 650-667nm<br>Red light LED: 645-<br>665nm | Subject<br>device is<br>within the<br>bandwidth<br>of predicate<br>and<br>reference<br>devices |
| Amount of laser<br>diodes | NEU300<br>Laser diodes: 100<br>LED diodes: 200 | Laser diodes: 26<br>LED diodes: 30 | | Subject<br>device is<br>within the<br>bandwidth<br>between<br>predicate<br>and<br>reference<br>devices |
| | NEU180<br>Laser diodes: 50<br>LED diodes: 130 | | Laser diodes: 250<br>LED diodes: 250 | Subject<br>device is<br>within the<br>bandwidth<br>between<br>predicate<br>and<br>reference<br>devices |
| Energy of per<br>laser diode | 5mW | 5mW | 5mW | Same |
| Treatment time | Each treatment: 25<br>mins<br>Total Treatment:<br>16 weeks, every<br>other day (indefinite) | Each treatment: 25<br>mins<br>Total Treatment:<br>16 weeks, every other<br>day (indefinite) | Each treatment:18<br>minutes or 27 minutes<br>Total Treatment:<br>16 weeks, every other<br>day (indefinite) | Same |
| Applicable<br>people | Norwood-Hamilton<br>IIa~V (males)<br>Ludwig-Savin I~II<br>(females) | Norwood-Hamilton<br>IIa~V (males)<br>Ludwig-Savin I~II<br>(females) | Norwood-Hamilton<br>IIa~V (males)<br>Ludwig-Savin I~II<br>(females) | Same |
| Applicable skin | Fitzpatrick Skin<br>Phototypes I-IV | Fitzpatrick Skin<br>Phototypes I-IV | Fitzpatrick Skin<br>Phototypes I-IV | Same |
| Helmet/Cap<br>design | Yes | Yes | Yes | Same |
| Comparison<br>Elements | Subject Device | Primary Predicate<br>Device | Reference device I | Remark |
| Biocompatibility<br>feature | All body-contacting<br>materials are<br>complied with<br>ISO10993-5 and<br>ISO 10993-10 | All body-contacting<br>materials are<br>complied with<br>ISO10993-5 and ISO<br>10993-10 | All body-contacting<br>materials are complied<br>with ISO10993-5 and<br>ISO 10993-10 | Same |

A technical comparison to the predicate is provided below:

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#### 7. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

#### Biocomnatibility Testing 1)

The biocompatibility evaluation for the body-contacting components of Neuhat Hair Growth System (or ibeauty.com Laser Cap) was conducted in accordance with the "Use of International Standard ISO 10993-1. 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:

- A ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
- A ISO 10993-10:2010. Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization

## 2) Electrical and EMC Safety

Electrical safety and EMC safety testing was performed to, and passed, the following standards:

- A IEC 60601-1 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
- A IEC 60601-4-2 Medical electrical equipment - Part 4-2: Guidance and interpretation -Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- A 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
- A IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: electromagnetic compatibility - Requirements and tests
- A 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
- A IEC 62471 Photobiological Safety of Lamps and Lamp Systems
- IEC 60825-1 Safety of laser products-Part 1: Equipment classification, and requirements A

#### 3) Summarv

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Based on the above performance as documented in this application, Neuhat Hair Growth System (or ibeauty.com Laser Cap) was found to have a safety and effectiveness profile that is same as the predicate device.

#### 8. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, Neuhat Hair Growth System (or ibeauty.com Laser Cap) is to be concluded same to its predicate devices and reference devices.