Irestore
iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood Hamilton Classifications…
iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood Hamilton Classifications of Ila to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV. The iRestore Hair Growth System uses 51 low-level lasers and 69 light-emitting diodes.
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 | Remax Medi-Tech(Shenzhen) Corporation, China |
|---|---|
| FDA product code | OAP |
| Device type | Laser, Comb, Hair |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5500 |
| Establishment | Manufacturer |
| Record published | 2022-03-21 |
| Record revised | 2022-12-12 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ID-500 | In distribution | |
| ID-500 | In distribution | |
| ID-510 | 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 |
| 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
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.