The following data is part of a premarket notification filed by Zhengzhou Bestview St Co., Ltd. with the FDA for Diode Laser Machine, Model Number: Bm-100.
| Device ID | K211335 |
| 510k Number | K211335 |
| Device Name: | Diode Laser Machine, Model Number: BM-100 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Zhengzhou Bestview St Co., Ltd. Room 204, 20F, Lande Center, Huayan Road, Jinshui District Zhengzhou, CN 450000 |
| Contact | Yangchun Jia |
| 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 | 2021-05-03 |
| Decision Date | 2021-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974892091016 | K211335 | 000 |
| 06974851081010 | K211335 | 000 |