Capillus
Cap for hair growth, photobiomodulation. 202 extra large sized laser diode device with 6 minute treatment time.
30manufacturers in China registered for this device type
29catalogue numbers in this listing
8510(k) clearances naming this product code
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 | Capillus, LLC, United States |
|---|---|
| FDA product code | OAP |
| Device type | Laser, Comb, Hair |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5500 |
| 510(k) | K143199 |
| Record published | 2022-12-29 |
| Record revised | 2020-07-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-09-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Focal Temple | In distribution | |
| One | In distribution | |
| Pro S2 | In distribution | |
| MD | In distribution | |
| Focal Crown | In distribution | |
| Rx | In distribution | |
| Spectrum | In distribution | |
| ultra | In distribution | |
| 272 Pro | In distribution | |
| Plus S1 | In distribution | |
| Pro XL | In distribution | |
| MD Duo | In distribution | |
| OfficePro 352 | In distribution | |
| 202XL | In distribution | |
| Tri Spectrum | In distribution | |
| 82 | In distribution | |
| Pro S1 | In distribution | |
| X+, HairClub X Plus Laser Cap | In distribution | |
| 272 Pro XL | In distribution | |
| Office Pro | In distribution | |
| ultra XL | In distribution | |
| 202 | In distribution | |
| One S | In distribution | |
| plus | In distribution | |
| Pro | In distribution | |
| Focal Medial | In distribution | |
| plus XL | In distribution | |
| Rx Duo | Withdrawn | |
| Spectrum MD | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K192012 | 2019-09-12 |
| K163170 | 2017-01-31 |
| K162994 | 2016-11-18 |
| K160285 | 2016-04-25 |
| K153618 | 2016-01-19 |
| K151516 | 2015-08-21 |
| K150578 | 2015-06-09 |
| K143199 | 2015-01-29 |
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.