The following data is part of a premarket notification filed by Xuzhou Yongkang Electronic Science Technology Co., Ltd with the FDA for Uv Radiation Treatment System.
| Device ID | K191571 |
| 510k Number | K191571 |
| Device Name: | UV Radiation Treatment System |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Xuzhou Yongkang Electronic Science Technology Co., Ltd 4F Building C8, 40 Jingshan Road, Economic And Technological Development Zone Xuzhou, CN 221000 |
| Contact | Kai Li |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2020-02-06 |