The following data is part of a premarket notification filed by Weifang Km Electronics Co., Ltd with the FDA for Diode Laser Treatment System.
| Device ID | K182924 |
| 510k Number | K182924 |
| Device Name: | Diode Laser Treatment System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Weifang KM Electronics Co., LTD No. 7999 Health East Street, High-tech District Weifang, CN 261000 |
| Contact | Andy Pang |
| Correspondent | Andy Pang Weifang KM Electronics Co., LTD No. 7999 Health East Street, High-tech District Weifang, CN 261000 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-19 |
| Decision Date | 2019-04-15 |