The following data is part of a premarket notification filed by Beijing Sincoheren Science And Tech. Development Co., Ltd with the FDA for Diode Laser Therapy Systems.
| Device ID | K152898 |
| 510k Number | K152898 |
| Device Name: | DIODE LASER THERAPY SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD ROOM 305, NO.43, XIZHIMEN NORTH STREET HAIDIAN DISTRICT Beijing, CN 100044 |
| Contact | Xin Wang |
| Correspondent | Mike Gu GUANGZHOU OSMUNDA MEDICAL DEVICE TECHNOLOGY SERVICE CO., LTD 7TH FLOOR, JINGUI BUSINESS BUILDING, NO.982 CONGYUN RD BAIYUN DISTRICT Guangzhou, CN 510420 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-01 |
| Decision Date | 2016-02-09 |
| Summary: | summary |