The following data is part of a premarket notification filed by Beijing Toplaser Technology Co., Ltd. with the FDA for Nd: Yag Laser System.
| Device ID | K133158 |
| 510k Number | K133158 |
| Device Name: | ND: YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BEIJING TOPLASER TECHNOLOGY CO., LTD. East 3rd Floor, Building M7, No.1 Jiuxianqiao East Road, Chaoyang District Beijing, CN 100015 |
| Contact | Zhang Xiaosong |
| Correspondent | Zhang Xiaosong BEIJING TOPLASER TECHNOLOGY CO., LTD. East 3rd Floor, Building M7, No.1 Jiuxianqiao East Road, Chaoyang District Beijing, CN 100015 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-02-28 |
| Summary: | summary |