The following data is part of a premarket notification filed by San He Lefis Electronics Co., Ltd. with the FDA for Diode Laser Therapy System.
| Device ID | K192569 |
| 510k Number | K192569 |
| Device Name: | Diode Laser Therapy System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | San He Lefis Electronics Co., Ltd. No. 1 Production Room., ChaoBai Street, West Yiangbin Road Yanjiao Development Zone, Sanhe County, , CN 300000 |
| Contact | Ning Li |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service 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 | 2019-09-18 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973011720035 | K192569 | 000 |
| 06973011720028 | K192569 | 000 |
| 06973011720011 | K192569 | 000 |