The following data is part of a premarket notification filed by Dongguan Lescolton Medical Equipment Co., Ltd with the FDA for Hair Growth Device.
|Device Name:||Hair Growth Device|
|Classification||Laser, Comb, Hair|
|Applicant||Dongguan Lescolton Medical Equipment Co., Ltd 402, Building 1, #3, Xinxing 3rd Road, Jiaoshe, Dongkeng Town Dongguan, CN 523443|
Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City, CN 510663
|CFR Regulation Number||890.5500 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|