The following data is part of a premarket notification filed by Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd with the FDA for Hair Growth Device.
| Device ID | K210169 |
| 510k Number | K210169 |
| Device Name: | Hair Growth Device |
| Classification | Laser, Comb, Hair |
| Applicant | Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd 401, Building 1, #3, Xinxing 3rd Road, Jiaoshe, Dongkeng Town Dongguan, CN 523586 |
| Contact | Liu Jianwen |
| Correspondent | Jinghua Zhou Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City, CN 510663 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-22 |
| Decision Date | 2021-04-16 |