The following data is part of a premarket notification filed by Zhengzhou Bestview St Co., Ltd. with the FDA for Co2 Laser Machine, Model: Bw-203b.
| Device ID | K211735 |
| 510k Number | K211735 |
| Device Name: | CO2 Laser Machine, Model: BW-203B |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Zhengzhou Bestview St Co., Ltd. Room 2004, 20F, Lande Center, Huayuan 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 | 2021-06-07 |
| Decision Date | 2021-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974892092013 | K211735 | 000 |
| 06974851082017 | K211735 | 000 |