The following data is part of a premarket notification filed by Zhongshan Bisen Plastic Electronic Products Co.,ltd. with the FDA for Red Light Device.
| Device ID | K162489 |
| 510k Number | K162489 |
| Device Name: | RED Light Device |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Zhongshan Bisen Plastic Electronic Products Co.,Ltd. F2,Bldg1,No.8,Dongzhen North Rd,Zhangjiabian 1st Vil Torch Development Zone Zhong Shan, CN 528437 |
| Contact | Fengping Li |
| Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd. Liyuan Town, Tongzhou District, Beijing, CN 101121 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-07 |
| Decision Date | 2017-01-13 |
| Summary: | summary |