The following data is part of a premarket notification filed by Beijing Lasertell Medical Co., Ltd. with the FDA for Diode Laser Therapy Systems.
| Device ID | K220381 |
| 510k Number | K220381 |
| Device Name: | Diode Laser Therapy Systems |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Beijing LaserTell Medical Co., Ltd. Block1, No.12 Jingsheng South 2nd Road, JQ Science Park, Tongzhou District Beijing, CN 101149 |
| Contact | Zeng Xun |
| 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 | 2022-02-10 |
| Decision Date | 2022-05-20 |