The following data is part of a premarket notification filed by Beijing Superlaser Technology Co., Ltd. with the FDA for Co2 Laser System.
| Device ID | K200042 |
| 510k Number | K200042 |
| Device Name: | CO2 Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Beijing Superlaser Technology Co., Ltd. No. 2 Zhongfu Street, E & T Industrial Zone xihongmen Tower, Daxing District Beijing, CN 100076 |
| Contact | Shi Shuang |
| 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 | 2020-01-08 |
| Decision Date | 2020-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973537444002 | K200042 | 000 |