(234 days)
Not Found
No
The device description focuses on the hardware components (LEDs, battery, timer) and the mechanism of action (red light therapy). There is no mention of software algorithms, data processing, or learning capabilities. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is indicated to treat Androgenetic Alopecia and promote hair growth, which are therapeutic claims.
No
The device description and intended use state that it treats Androgenetic Alopecia and promotes hair growth. There is no mention of the device being used to diagnose or detect a condition.
No
The device description explicitly details hardware components including a fabric cap with inbuilt LED diodes, an attachable controller battery pack, and a USB connector. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The PBM Hair Therapy Cap is a light therapy device that applies red light directly to the scalp. It does not analyze any samples taken from the body.
- Intended Use: The intended use is to treat Androgenetic Alopecia and promote hair growth, which is a therapeutic application, not a diagnostic one.
The device description and intended use clearly indicate it's a therapeutic device for external use, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
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 comes with a Cap that has LED diodes inbuilt and an attachable controller battery pack that comes with an automatic timer that limits 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 lithium-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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.
1
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).
2
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 (1-800-638-2041 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
3
Indications for Use
Submission Number (if known)
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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4
| 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 | stephenprior@tutamen.net | ||||||
| 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 | cdzhafarov@meddevpath.com | ||||||
| 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) | |||||||
| 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 | |||||||
| comes with a Cap that has LED diodes inbuilt and an attachable controller battery pack that comes with an automatic timer that limits | |||||||
| 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
5
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)