The following data is part of a premarket notification filed by Beijing Globalipl Development Co., Ltd. with the FDA for Us 450 Diode Laser Equipment.
| Device ID | K222916 |
| 510k Number | K222916 |
| Device Name: | US 450 Diode Laser Equipment |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Beijing Globalipl Development Co., Ltd. F-8 Qunyinghui Building, Jinyuan Rd.32, Daxing Economic Development Zone Beijing, CN 102628 |
| Contact | Liu Jun |
| 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 | 2022-09-26 |
| Decision Date | 2022-12-09 |