FAQ 302
FAQ 302 is a handheld rechargeable light device intended to promote hair growth in androgenetic alopecia. It uses 20 laser diodes at 650 ± 10 nm and 20 red LEDs emitting from 640 to 660 nm.…
FAQ 302 is a handheld rechargeable light device intended to promote hair growth in androgenetic alopecia. It uses 20 laser diodes at 650 ± 10 nm and 20 red LEDs emitting from 640 to 660 nm.
The indication covers males with Hamilton-Norwood classes IIa to V and females with Ludwig-Savin classes I to II, with Fitzpatrick skin phototypes I to IV. It is intended for over-the-counter home use.
Listed Item
FAQ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of l-II and Fitzpatrick Classification of Skin Phototypes I to IV.
Treatment Controls
A universal button controls power, treatment and intensity, while an optional Bluetooth connection to the FAQ app manages treatment. The regimen is eight minutes every other day. A built-in lithium battery powers the device, which automatically switches off after treatment.
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 | Foreo Inc, United States |
|---|---|
| FDA product code | OAP |
| Device type | Laser, Comb, Hair |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5500 |
| Establishment | Complaint-file establishment |
| 510(k) | K242747 |
| Record published | 2024-12-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Black Diamond | 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 |
| Hair Growth Device | Dongguan Boyuan Intelligent Technology Co., Ltd. | 2 |
| Medi Tresse LaserCap HD | LaserCap Company | 2 |
Showing 12 of 66. All products under Laser, Comb, Hair
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242747 | 2024-12-11 |
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.