The following data is part of a premarket notification filed by Beijing Toplaser Technology Co., Ltd. with the FDA for Speed 808 Diode Laser System.
| Device ID | K132989 |
| 510k Number | K132989 |
| Device Name: | SPEED 808 DIODE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BEIJING TOPLASER TECHNOLOGY CO., LTD. EAST 3RD FL, BLDG M7 # 1 JIUXIANQIAO EAST RD Chaoyang District, Beijing, CN 100015 |
| Contact | Zhang Xiaosong |
| Correspondent | Zhang Xiaosong BEIJING TOPLASER TECHNOLOGY CO., LTD. EAST 3RD FL, BLDG M7 # 1 JIUXIANQIAO EAST RD 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 | 2013-09-24 |
| Decision Date | 2014-01-23 |
| Summary: | summary |