The following data is part of a premarket notification filed by Foshan Coxo Medical Instrument Co., Ltd. with the FDA for Led Curing Light.
| Device ID | K220826 |
| 510k Number | K220826 |
| Device Name: | LED Curing Light |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | Foshan COXO Medical Instrument Co., Ltd. BLDG 4, District A, Guangdong New Light Source Industrial Base, South Of Luocun Avenue Nanhai District, Foshan, CN 528226 |
| Contact | Yongjian Zheng |
| 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 | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-22 |
| Decision Date | 2022-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974267890565 | K220826 | 000 |