The following data is part of a premarket notification filed by Touchbeauty Beauty & Health (shenzhen) Co., Ltd. with the FDA for Ipl Hair Removal Device.
| Device ID | K183217 |
| 510k Number | K183217 |
| Device Name: | IPL Hair Removal Device |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. 7/F, Marina Bay Centre A, South Of Xinhua Road Bao’an District Shenzhen, CN |
| Contact | Aaron Zhai |
| Correspondent | Jet Li Guangzhou KEDA Testing Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-02-15 |
| Summary: | summary |