The following data is part of a premarket notification filed by Guangzhou Huafei Tongda Technology Co., Ltd. with the FDA for Diode Laser System.
| Device ID | K181019 |
| 510k Number | K181019 |
| Device Name: | Diode Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Guangzhou Huafei Tongda Technology Co., Ltd. 4/F, Building B Industrial And Commercial Trading Park, Hainan Town Huadi Dadao Nan Road, Fangcun, Liwan Dis, CN 510388 |
| Contact | Liu Pengqi |
| Correspondent | Ray Wang Beijing Believe-Med Technology Services Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, CN 102401 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-17 |
| Decision Date | 2018-07-16 |
| Summary: | summary |