PBM Hair Therapy Cap

K240472 · Dongguan Tutamen Metalwork Co., Ltd. · OAP · Oct 11, 2024 · Physical Medicine

Device Facts

• Record ID: K240472
• Device Name: PBM Hair Therapy Cap
• Applicant: Dongguan Tutamen Metalwork Co., Ltd.
• Product Code: OAP · Physical Medicine
• Decision Date: Oct 11, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PBM Hair Therapy Cap is indicated to treat And promote hair growth in females who have Ludwig-Savin Scale I to II, males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss, females and males with frontal patterns of hair-loss both with Fitzpatrick Skin Types I to IV.

Device Story

PBM Hair Therapy Cap; fabric cap with 84 inbuilt 660nm red LED diodes (7 strips, 12 diodes/strip); battery-powered controller; OTC use for hair growth stimulation; user-operated; 15-minute automatic timer; USB-C charging; LED indicators for power/charging status; device emits red light to scalp; intended to treat androgenetic alopecia; benefits include potential hair growth promotion.

Clinical Evidence

Bench testing only. Verification of requirements (VR0001) and usability testing (US001) performed in accordance with IEC 62366-1:2015.

Technological Characteristics

Fabric cap with 84 red LED diodes (660nm); 3.7V lithium-ion battery; USB-C charging; 15-minute automatic timer; Class 3R laser system per IEC standards.

Indications for Use

Indicated for females with Ludwig-Savin Scale I-II and males with Norwood Hamilton Classifications IIa-V androgenetic alopecia; includes frontal hair loss patterns; applicable to Fitzpatrick Skin Types I-IV.

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

• The Time Machine Series Lasers

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's full name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

October 11, 2024

Dongguan Tutamen Metalwork Co., Ltd Caitlyn Dzhafarov Sr. Regulatory Consultant No.3, Huangguotang Road Tangxia Town DongGuan, 523000 China

Re: K240472

Trade/Device Name: PBM Hair Therapy Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: October 10, 2024 Received: February 20, 2024

Dear Caitlyn Dzhafarov:

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/ofdocs/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.

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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 (OS) 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 820.70) 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 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-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 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 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-device-advicecomprehensive-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-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).

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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-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@;tda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

TANISHA TANISHA L. HITHE -S L. HITHE -S Date: 2024.10.11
2020-02-02:43 -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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## Indications for Use

Submission Number (if known)

K240472

Device Name

PBM Hair Therapy Cap

#### Indications for Use (Describe)

The PBM Hair Therapy Cap is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I to II, males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss, females and males with frontal patterns of hair-loss both with Fitzpatrick Skin Types I to IV.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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| 510(k) #: | K240472 | | 510(k) Summary | | | Prepared on: 2024-10-10 | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------|------------------------------------------------------------|--|-----|-------------------------|--|
| Contact Details | | | | | | 21 CFR 807.92(a)(1) | |
| Applicant Name | | | Dongguan Tutamen Metalwork Co., LTD. | | | | |
| Applicant Address | | | No.3, Huangguotang Road Tangxia Town DongGuan 523000 China | | | | |
| | Applicant Contact Telephone | | 760-402-7859 | | | | |
| Applicant Contact | | | Mr. Stephen Prior | | | | |
| Applicant Contact Email | | | [e-mail] | | | | |
| Correspondent Name | | | Medical Devices Pathway, LLC. | | | | |
| Correspondent Address | | | 14330 178th Ln NE Woodinville WA 98072 United States | | | | |
| Correspondent Contact Telephone | | | 3602243622 | | | | |
| Correspondent Contact | | | Ms. Caitlyn Dzhafarov | | | | |
| Correspondent Contact Email | | | [e-mail] | | | | |
| Device Name | | | | | | 21 CFR 807.92(a)(2) | |
| Device Trade Name | | | PBM Hair Therapy Cap | | | | |
| Common Name | | | Infrared lamp | | | | |
| Classification Name | | | Laser, Comb, Hair | | | | |
| Regulation Number | | | 890.5500 | | | | |
| Product Code | | | OAP | | | | |
| Legally Marketed Predicate Devices | | | | | | 21 CFR 807.92(a)(3) | |
| Predicate Trade Name (Primary Predicate is listed first)<br>Predicate # | | | | | | Product Code | |
| K173729 | | Revian Red | | | OAP | | |
| Device Description Summary | | | | | | 21 CFR 807.92(a)(4) | |
| The PBM Hair Therapy Cap is a hair therapy device that uses red light to help stimulate hair growth in both male and females. The device<br>comes with a Cap that has LED diodes inbuilt and an attachable controller battery pack that comes with an automatic timer that limits<br>the user to 15-minute sessions. | | | | | | | |

The device uses only 660nm LED wavelength diodes on 7 strips, each strip has 12 diodes. These diodes strips are sewn into a cap and has a Type C USB connector that the controller battery pack can connect to.

The PBM Hair Therapy Cap is comprised of a fabric cap with inbuilt LED diodes that emit red light on the wavelength of 660nm. The diodes are on strips and the cap style hat has 7 strips with 12 diodes on each strip with a total of 84 LED diodes.

A battery powered controller that attaches via a C-type USB connector to the fabric hat is also provided. The controller has a built in 3.7V

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ithium-ion battery, has an on/off button and in programmed to automatically turn of after 15min of use. The controller also has a 2 small indicator LED's for indicating, power on/in use, needs charging and also blinks while in charging mode. The controller charges via inbuilt C-Type USB port and charges at 500 mA.

## Intended Use/Indications for Use

The PBM Hair Therapy Cap is indicated to treat And promote hair growth in females who have Ludwig-Savin Scale I to II, males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss, females and males with frontal patterns of hair-loss both with Fitzpatrick Skin Types I to IV.

## Indications for Use Comparison

The indications for use statements are substantially equivalent, just worded sightly differently. Both are indicated for the same patient populations and have the same intended use.

# Technological Comparison

Both the PBM Hair Therapy Cap Device and Revian Red utilize LLLT mechanism of action with textile hair growth on the scalp in the same indicated patient population. The technical specifications of the PBM Hair Therapy Cap and the predicate Revian Red are comparable. The noted minor differences in technological characteristics, such as battery types (lithium polymer), wave-lengths (660 nm) and number of red LEDs (84 versus 119 Red LEDs) and treatment durations (15 minutes versus 10 minutes), are considered negligible and do not affect the therapeutic value or safety profile. Both devices are classified as class 3R laser systems in accordance with IEC standards and share a substantially equivalent adverse event profile. Many of the characteristics which differ between the PBM Hair Therapy Cap and the predicate, The Time Machine Series Lasers device, are due to the PBM Hair Therapy Cap being a subset of the intended use and indications for use of the predicate device and fall within the cleared spectrum of technical characteristics of the predicate device (e.g. fall within the cleared wavelength, etc.). None of these differences raises new or different questions of safety or effectiveness.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Verification of requirements (VR0001) and usability testing (US001, in accordance with IEC 62366-1:2015 and Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff)

### Not Applicable

With respect to the PBM Hair Therapy Cap comparison to a predicate device, Revian Red, the PBM Hair Therapy Cap has the same intended use, similar technological characteristics, and for minor differences in technological characteristics, these have been determined to not raise and different questions of safety or effectiveness. Scientific data supporting safety and effectiveness have been provided and are similar to the data required for the legally marketed predicate device. The totality of non-clinical data provides valid scientific evidence to support the conclusion that there are no different questions of safety and effectiveness raised when compared to the predicate device. This data demonstrates the PBM Hair Therapy Cap is substantially equivalent to the predicate Revian Red based upon the totality of the evidence.

## 21 CFR 807.92(a)(5)

21 CFR 807.92(a)(5)

# 21 CFR 807.92(a)(6)