The following data is part of a premarket notification filed by Beijing Sincoheren Science And Technology Development Co. with the FDA for Q-switched Nd:yag Laser Therapy Systems.
| Device ID | K163123 |
| 510k Number | K163123 |
| Device Name: | Q-Switched Nd:YAG Laser Therapy Systems |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. ROOM 305, NO.43, XIZHIMEN NORTH STREET, HAIDIAN DISTRICT Beijing, CN 100044 |
| Contact | Huan Kong |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Services Co.,Ltd. 8-9Th Floor, R&D Building, No.26 Qinglan St, Panyu District Guangzhou, CN 510006 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-08 |
| Decision Date | 2017-02-02 |
| Summary: | summary |