Xtrallux™
The FDA filing describes Xtrallux as a family of non-invasive, low-level laser devices with red visible-light diode lasers operating at 650 nm. The diodes are housed in a cap between an…
The FDA filing describes Xtrallux as a family of non-invasive, low-level laser devices with red visible-light diode lasers operating at 650 nm. The diodes are housed in a cap between an outer shell and inner liner.
The filing names Alpha, Super Plus, Turbo Pro and Extreme RX models. It states that these devices are intended to treat androgenetic alopecia and promote hair growth for specified male and female hair-loss patterns and skin types.
Listed Item
Xtrallux™ Super Plus Hair Regrowth Cap – Photobiomodulating Device – Large Size
Named Models
The FDA summary names four Xtrallux models: Alpha, Super Plus, Turbo Pro and Extreme RX.
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 | Xtrallux, LLC, United States |
|---|---|
| FDA product code | OAP |
| Device type | Laser, Comb, Hair |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5500 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K222364 |
| Record published | 2023-11-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Xtrallux™ Extreme RX | In distribution | |
| Xtrallux™ Turbo Pro | In distribution | |
| Xtrallux™ Super Plus Reg Size | In distribution | |
| Xtrallux™ Premium | In distribution | |
| Xtrallux™ Alpha | In distribution | |
| Xtrallux™ Advanced | In distribution | |
| Xtrallux™ Super Plus | In distribution | |
| Xtrallux™ Elite | In distribution | |
| Laser Comb Alpha | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Capillus | Capillus, LLC | 29 |
| HairMax | Lexington Medical, Inc. | 16 |
| 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 |
| 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 |
|---|---|
| K222364 | 2022-11-16 |
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.