The following data is part of a premarket notification filed by Chongqing Peninsula Medical Technology Co., Ltd. with the FDA for 308nm Excimer System.
| Device ID | K192642 |
| 510k Number | K192642 |
| Device Name: | 308nm Excimer System |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Chongqing Peninsula Medical Technology Co., Ltd. No.2-4, 2F Block I, Ke Yuan 4th Road, Jiulongpo District Chongqing, CN 400041 |
| Contact | Zhang Sudi |
| Correspondent | Cassie Lee Guangzhou GLOMED Biologcial Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou Guangzhou, CN 510000 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-24 |
| Decision Date | 2020-05-13 |