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 |