The following data is part of a premarket notification filed by Zhongshan Bisen Plastic Electronic Products Co., Ltd. with the FDA for Ipl Hair Removal Device.
| Device ID | K212314 |
| 510k Number | K212314 |
| Device Name: | IPL Hair Removal Device |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Zhongshan Bisen Plastic Electronic Products Co., Ltd. Second Floor, A Building, No.32 JianYe Road, Torch Development Zone Zhongshan, CN 528437 |
| Contact | Rao Guanhua |
| Correspondent | Mark Leung Shenzhen Joyantech Consulting Co.,Ltd. 1713A, Block A, Zhongguan Times Square Liuxian Avenue, Xili Town Shenzhen, CN 518000 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-23 |
| Decision Date | 2021-10-21 |