(85 days)
No. The term "intelligent LLLT technology" is used, but the document does not provide details of any AI, machine learning, or deep learning models, nor does it describe any associated training or test sets that would typically be required for an AI model. The device description explicitly states "no communication function," further suggesting a lack of complex processing that would involve an AI model.
Yes.
The device is intended to treat a medical condition (Androgenetic Alopecia/Hair Loss) and promote a physiological change (hair growth), which are characteristics of a therapeutic device.
No
The device is intended to treat androgenetic alopecia and promote hair growth, not to diagnose a condition.
No
The device description explicitly states "The product is composed of main unit, USB cable, and silicone pad. The main unit consists of laser diodes that are spread throughout the helmet." and "Hair Growth Device is a small over-the-counter, portable, noninvasive, low-level laser device". This confirms the device is a physical hardware product that delivers laser therapy, not a software-only medical device. While it mentions "Software validation" in the performance studies, this refers to software embedded within the hardware, not a standalone software product.
No.
Reasoning: The device is a "Hair Growth Device" that uses low-energy laser therapy to promote hair growth in individuals with androgenetic alopecia. It is a physical therapy device that acts directly on the body (scalp and hair follicles) and does not involve the in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Product codes
OAP
Device Description
The product is composed of main unit, USB cable, and silicone pad. The main unit consists of laser diodes that are spread throughout the helmet.
Low-energy laser therapy (LLLT) is a safe and effective treatment for androgenic alopecia (AGA). The Hair Growth Device employs intelligent LLLT technology, utilizing a 650 nm, 5-milliwatt low-energy laser that penetrates the scalp surface to a depth of 3-5 mm, reaching the hair follicles.
Hair Growth Device is a small over-the-counter, portable, noninvasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. Hair Growth Device consists of main unit, USB cable and silicone strap and no communication function. The device will then turn on and you'll hear an audible beep.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp / Head
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
A series of safety and performance tests were conducted on the subject device.
- Product service life
- Software validation
- Biocompatibility evaluation
- Electromagnetic compatibility and electrical safety
- Safety of laser products
- Performance test
All the test results demonstrate Hair Growth Device meets the requirements of its predefined acceptance criteria and intended use, and it is substantially equivalent to the predicate devices.
No clinical test data was used to support the decision of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
FDA 510(k) Clearance Letter - Hair Growth Device
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
April 29, 2025
Dongguan Boyuan Intelligent Technology Co., Ltd.
℅ Reanny Wang
General Manager
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Room 1509, Jingting Building, Dongzhou Community,
Guangming Street, Guangming District
Shenzhen, Guangdong 518107
China
Re: K250308
Trade/Device Name: Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
Regulation Number: 21 CFR 890.5500
Regulation Name: Infrared Lamp
Regulatory Class: Class II
Product Code: OAP
Dated: January 27, 2025
Received: February 3, 2025
Dear Reanny Wang:
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.
Page 2
K250308 - Reanny Wang Page 2
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.
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.
Page 3
K250308 - Reanny Wang Page 3
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. 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: 2025.04.29 15:17:28 -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
Page 4
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): K250308
Device Name: Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
Indications for Use (Describe):
Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) number: K250308
1. Information of Submitter and Correspondent
Submitter's information:
- Company Name: Dongguan Boyuan Intelligent Technology Co., Ltd.
- Street Address: Room 801, Building 3, No.3 Kuiqiao Road, Puxin Lake, Tangxia Town, Dongguan, Guangdong, China.
- City: Dongguan
- State/ Province: Guangdong
- Country: China
- Telephone: +86-13422889315
- Contact Person: Li Jinlong
- Contact Title: General Manager
- Contact Email: 978953150@qq.com, reanny@reanny.com
- Date Prepared: Apr. 28, 2025
Submission correspondent's information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
Address: Room 1509, Jingting Building, Dongzhou Community, Guangming Street, Guangming District, Shenzhen 518107, China
Contact Person: Reanny Wang
E-mail: reanny@reanny.com
Phone: +86(755) 27391220
2. Device Information
- Trade Name: Hair Growth Device
- Model: KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S
- Common Name: Laser, Comb, Hair
Page 6
- Classification Name: Infrared lamp
- Regulation: 21 CFR 890.5500
- Device Class: Class 2
- Product Code: OAP
3. Identification of Predicate Device(s)
| Substantial equivalent devices | Sponsor | Trade Name | 510(k) number | Product Code | Regulation Number | Approval Date |
|---|---|---|---|---|---|---|
| Predicate device | Slinph Technologies Co., Ltd. | iHelmet Hair Growth System | K162782 | OAP | 21 CFR 890.5500 | April 4, 2017 |
| Reference device | DermaScalp LLC | DermaScalp Laser Caps | K173846 | OAP | 21 CFR 890.5500 | March 21, 2018 |
| Reference device | PhotonMD, Inc | REVIAN RED | K173729 | OAP | 21 CFR 890.5500 | February 28, 2018 |
4. Description of Device
The product is composed of main unit, USB cable, and silicone pad. The main unit consists of laser diodes that are spread throughout the helmet.
Low-energy laser therapy (LLLT) is a safe and effective treatment for androgenic alopecia (AGA). The Hair Growth Device employs intelligent LLLT technology, utilizing a 650 nm, 5-milliwatt low-energy laser that penetrates the scalp surface to a depth of 3-5 mm, reaching the hair follicles.
Hair Growth Device is a small over-the-counter, portable, noninvasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. Hair Growth Device consists of main unit, USB cable and silicone strap and no communication function. The device will then turn on and you'll hear an audible beep.
5. Indications for Use
Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
6. Discussion of Comparison to Predicate Devices.
The Hair Growth Device submitted in this 510(k) submission is compared in intended use, technological characteristics and performance to the cleared iHelmet Hair Growth System K162782, DermaScalp Laser Caps K173846 and REVIAN RED K173729.
Page 7
| Device | Subject device | Primary Predicate device | Primary reference device | Primary reference device | Comparison |
|---|---|---|---|---|---|
| Manufacturer | Dongguan Boyuan Intelligent Technology Co., Ltd. | Slinph Technologies Co., Ltd. | DermaScalp LLC | PhotonMD, Inc | NA |
| 510(K) number | Pending | K162782 | K173846 | K173729 | NA |
| Product name | Hair Growth Device | iHelmet Hair Growth System | DermaScalp Laser Caps | REVIAN RED | NA |
| Classification | Class II Device, OAP (21 CFR890.5500) | Class II Device, OAP (21 CFR890.5500) | Class II Device, OAP (21 CFR890.5500) | Class II Device, OAP (21 CFR890.5500) | Same Classification |
| Classification Name | Infrared Lamp | Infrared Lamp | Infrared Lamp | Infrared lamp | Same |
| Indications for Use (IFU) | Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV. | iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV. | The family of DermaScalp Laser Cap devices are indicated to treat Androgenetic Alopecia and promote hair growth in Males who have Norwood Hamilton Classifications of IIa to 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; both with Fitzpatrick Skin Types I to IV. | REVIAN RED is indicated to treat Androgenetic Alopecia and 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. | Same |
| Model | KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S,KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S | LTD200S | -- | --- | NA |
Page 8
| Device | Subject device | Primary Predicate device | Primary reference device | Primary reference device | Comparison |
|---|---|---|---|---|---|
| OTC or Rx | OTC | OTC | OTC | OTC | Same Classification |
| Product Code | OAP | OAP | OAP | OAP | Same |
| Waveform | Visible red laser | Visible red laser | 119 Red LEDs | 119 Red LEDs | Same |
| Wavelength | 650nm±20nm | 650nm±10nm | 650 nm | 620 - 660 nm | Same |
| Amounts of Laser Lamp | 56, 88, 120, 200 | 200 | 50, 80, 120, 148, 180, 202, 224, 272 | 51, 80 | Minor different Note 1 |
| Energy of per Laser Lamp | 5mW | 4~5mW | ˂ 5mW | -- | Same |
| Classification according to IEC60825-1 | Class 3R | Class 3R | Class 3R | Class 3R | Same |
| Treatment Time | Each Treatment: 30 minutes. Total Treatment: once every 2 days, for 16 weeks | Each Treatment: 20-35 min Total Treatment: every other day, for 16 weeks | Treatment - 17weeks, every other day (indefinite) | -- | Minor different Note 1 |
| Treatment Area | 390cm² Mathematically Max. derived | 424.93 cm2 Mathematically Max. derived | -- | -- | Minor different Note 1 |
| Irradiance (power per area) | 2.56mw/cm² Mathematically Max. derived | 2.3533 mW/cm2 Mathematically Max. derived | -- | 1.67 mW/cm2 | Minor different Note 1 |
| Fluence | KCA441-200, KCA451-200, KCA441-200S, KCA451-200S 4.62J/cm²; KCA441-88, KCA451-88, KCA441-120S, KCA451-120S 2.03J/cm² | 4.9420 J/ cm2 Mathematically Max. derived | -- | -- | Minor different Note 1 |
Page 9
| Device | Subject device | Primary Predicate device | Primary reference device | Primary reference device | Comparison |
|---|---|---|---|---|---|
| KCA441-120, KCA451-120: KCA441-88, SKCA451-88S 2.77J/cm²; KCA441-56, KCA451-56, KCA441-56S, KCA451-56S 1.29J/cm² | |||||
| Dimension | KCA441size: 26cm x 21cm x 12.5cm KCA451size: 26cm x 21cm x 13cm | 266mm x 196mm x 135mm (L x W x H) | -- | Height: 15.87 cm (6.25 in) x Width: 20 cm (7.87 in) x Length: 22.86 cm (9 in) | Minor different Note 2 |
| Weight | KCA441 size:572g KCA451 size: weight:567g | 600g | -- | 155 g | Minor different Note 2 |
| Environment for Operation | Temperature: 5℃ | Temperature: 15 | -- | 5-35˚C (41-95˚F) Humidity: Up to 90%, non-condensing Atmospheric Pressure: 700 hPa to 1060 hPa | Minor different Note 3 |
| Environment for Storage | Temperature: -20℃ | Temperature: -20 | -- | Temperature: 15-35˚C (59-95˚F) Humidity: Up to 90%, non-condensing Atmospheric Pressure: 700 hPa to 1060 hPa | Minor different Note 3 |
| Standards | IEC 60601-1 IEC 60601-1-2 IEC 60825-1 IEC 60601-1-11 ISO 10993-5 ISO 10993-10 | IEC 60601-1 IEC 60601-1-2 IEC 60825-1 IEC 60601-1-11 ISO 10993-5 ISO 10993-10 | IEC 60601-1 IEC 60601-1-2 IEC 60825-1 IEC 60601-1-11 ISO 10993-5 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-57 ISO 10993-1 IEC 62366-1 IEC 60601-1-6 | Minor different Note 4 |
Page 10
Note 1:
Although the "Amounts of Laser Lamp", "Treatment Time", "Treatment Area", "Irradiance", and "Fluence" of subject device and predicate device are a little difference, the energy and power parameters' range of subject device can be covered by predicate device's several models' range; they are very similar. So these parameters' differences will not raise any safety or effectiveness issue.
Note 2:
The Dimensions and Weigh of subject device, predicate devices and reference devices are difference, but they belong to portable device, only the size, weight and service life are difference, they are both complied with IEC 60601-1, so the differences do not affect the safety and effectiveness.
Note 3:
The "Operating environment" and "Transportation & Storage environment" of subject devices may be differ from the predicate devices and reference devices, but they are both compliance with the IEC 60601-1 and IEC 60601-1-11 standards, so the difference will not raise any safety or effectiveness issue.
Note 4:
They are both complied with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 and ISO 10993-1. IEC 60601-2-57 is for non-laser light source equipment, so the difference will not raise any safety or effectiveness issue.
Conclusions:
The subject device Hair Growth Device (Model: KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) has been compared with iHelmet Hair Growth System (K162782), DermaScalp Laser Caps (K173846) and REVIAN RED (K173729). The subject device has same intended use, similar technological characteristics as that of predicate devices and reference devices. Although there are several specifications that are different between the subject device, predicate devices and reference devices, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the differences between the subject device, the predicate devices and reference devices do not raise any concerns with respect to substantial equivalence. The subject device is substantially equivalent to the predicate devices.
Page 11
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
7.1 Non-clinical testing
A series of safety and performance tests were conducted on the subject device.
- Product service life
- Software validation
- Biocompatibility evaluation
- Electromagnetic compatibility and electrical safety
- Safety of laser products
- Performance test
All the test results demonstrate Hair Growth Device meets the requirements of its predefined acceptance criteria and intended use, and it is substantially equivalent to the predicate devices.
7.2 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
8. Conclusions
The results of the tests described above demonstrate that Hair Growth Device is as safe and effective as the predicate devices and supports a determination of substantial equivalence.