Hair Growth Device
Hair Growth Device from Dongguan Boyuan uses a helmet-mounted array of low-level laser diodes to promote hair growth in specified androgenetic alopecia populations. The stationary array…
Hair Growth Device from Dongguan Boyuan uses a helmet-mounted array of low-level laser diodes to promote hair growth in specified androgenetic alopecia populations. The stationary array covers the scalp without manual scanning.
The system emits 650 nm laser light and includes a main unit, USB cable and silicone support. It is portable, noninvasive and intended for over-the-counter use.
Listed Item
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 and rogenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Eligible Hair-Loss Patterns
The indication covers women with Ludwig-Savin classifications I to II and men with Norwood-Hamilton classifications IIa to V. Both groups must have Fitzpatrick skin phototypes I to IV. These limits define the hair-loss and skin-type populations for the device.
Who Else Makes It
Concentrated in Guangdong (18), Zhejiang (2), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Shenzhen Allbeauty Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Hebei Tuosite Technology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 14 |
| Guangdong Fuqiang Beauty Equipment Co., Limited | Qingyuan | Guangdong | Manufacturer | 13 |
| Dongguan Tutamen Metalwork Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 12 |
| Hubei YJT Intelligent Technology Group Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 12 |
| Shenzhen Willcareyou Technology Co., Ltd. | Shenzhen | Guangdong | Remanufacturer | 10 |
| VIS (Shanghai) Technology Co., Ltd. | Jinshan District | Shanghai | Manufacturer | 10 |
| Zdeer Technology (Henan) Co., Ltd. | Xuchang | Henan | Remanufacturer | 9 |
Showing 12 of 30. All 30 manufacturers in China registered for Laser, Comb, Hair
Record
| Listed by | Dongguan Boyuan Intelligent Technology Co., Ltd., China |
|---|---|
| FDA product code | OAP |
| Device type | Laser, Comb, Hair |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5500 |
| Establishment | Manufacturer |
| 510(k) | K250308 |
| Record published | 2026-07-09 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KCA441-200S | In distribution | |
| KCA451-200S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Capillus | Capillus, LLC | 29 |
| HairMax | Lexington Medical, Inc. | 16 |
| Xtrallux™ | Xtrallux, LLC | 9 |
| CurrentBody Skin™ | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 6 |
| Kernel | Xuzhou Kernel Medical Equipment Co Ltd | 5 |
| Diode Laser Cap | Cosmo FAR East Technology Limited | 4 |
| RedRestore | 10589578 Canada Inc. | 4 |
| Newhair Laser Hair Growth CAP | Shang FAR Biotechnology Co. | 4 |
| iRestore | Remax Medi-Tech(Shenzhen) Corporation | 3 |
| Hairclub RX™ | Xtrallux, LLC | 3 |
| Medi Tresse LaserCap HD | LaserCap Company | 2 |
| Laser, Comb, Hair | Dongguan Boyuan Intelligent Technology Co., Ltd. | 2 |
Showing 12 of 66. All products under Laser, Comb, Hair
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250308 | 2025-04-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.