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 ID | K221002 |
| 510k Number | K221002 |
| 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 |
| Contact | Xiaoming Lin |
| Correspondent | Tracy Che Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, CN 518052 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-04 |
| Decision Date | 2022-06-01 |