The following data is part of a premarket notification filed by Beijing Globalipl Development Co., Ltd. with the FDA for Ipl + Diode Laser Machine.
| Device ID | K193328 |
| 510k Number | K193328 |
| Device Name: | IPL + Diode Laser Machine |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | Beijing Globalipl Development Co., Ltd. F-8 Qunyinghui Building, Jinyuan Rd.32 Daxing Economic Development Zone, Beijing, CN 102628 |
| Contact | Li Ye |
| 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 | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-02 |
| Decision Date | 2020-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973494934196 | K193328 | 000 |
| 00860007876806 | K193328 | 000 |