The following data is part of a premarket notification filed by Xuzhou Kernel Medical Equipment Co., Ltd. with the FDA for Hair Growth System.
| Device ID | K190685 |
| 510k Number | K190685 |
| Device Name: | Hair Growth System |
| Classification | Laser, Comb, Hair |
| Applicant | Xuzhou Kernel Medical Equipment Co., Ltd. Kernel Mansion, Economic Development District Xuzhou, CN |
| Contact | Wang Jing |
| Correspondent | Jet Li Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2019-07-26 |
| Summary: | summary |