EVO LH40
The Theradome EVO LH40 is a laser helmet intended to promote hair growth in women with androgenetic alopecia. Forty red laser diodes deliver nonthermal light at 678 nm across the scalp…
The Theradome EVO LH40 is a laser helmet intended to promote hair growth in women with androgenetic alopecia. Forty red laser diodes deliver nonthermal light at 678 nm across the scalp while the helmet is worn.
A single button starts treatment, and an audible timer accompanies automatic shutoff after a 20-minute session. The helmet design allows hands-free use during the treatment.
Listed Item
Theradome EVO LH40 laser helmet is a low level laser therapy (LLLT) devices containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp.
Indicated Users
This model is intended for female pattern hair loss graded I to II on the Ludwig and Savin scales and Fitzpatrick skin types I to IV. The described regimen is four treatments per week. It is supplied for over-the-counter use.
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 | Theradome, Inc., United States |
|---|---|
| FDA product code | OAP |
| Device type | Laser, Comb, Hair |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5500 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K161046 |
| Record published | 2020-12-02 |
| Record revised | 2023-03-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 70 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 105 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EVO LH40 | 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 |
|---|---|
| K180460 | 2018-05-18 |
| K171775 | 2018-01-09 |
| K161046 | 2016-05-12 |
| K122950 | 2013-06-14 |
| K113097 | 2012-03-02 |
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.