The following data is part of a premarket notification filed by Shenzhen Ulike Smart Electronics Co.,ltd with the FDA for Ipl Hair Removal Device, Model(s): Ui04a, Ui04b, Ui04c.
|Device Name:||IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C|
|Classification||Light Based Over-the-counter Hair Removal|
|Applicant||Shenzhen Ulike Smart Electronics Co.,Ltd No.8, Keyuan Road, Yuehai Subb-district, Nanshan District, Shenzhen Shenzhen, CN 518000|
Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, CN 518052
|CFR Regulation Number||878.4810 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|