The following data is part of a premarket notification filed by Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd with the FDA for Ipl Hair Removal Device (model: Kca423).
| Device ID | K210119 |
| 510k Number | K210119 |
| Device Name: | IPL Hair Removal Device (Model: KCA423) |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd RM202-203, Y2 Building, Chuangyi Park, Bantian Town, Long Gang District Shenzhen, CN |
| Contact | Cheryl Yang |
| Correspondent | Iris Fung SGS-CSTC Standards Technical Services Co., Ltd. 198 Kezhu Road, SCIENTECH Park Guangzhou Economic & Technology Development Guangzhou, CN |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973006910175 | K210119 | 000 |
| 06975587680003 | K210119 | 000 |