The following data is part of a premarket notification filed by Beijing Superlaser Technology Co., Ltd. with the FDA for Multi-modality Workstation.
| Device ID | K192519 |
| 510k Number | K192519 |
| Device Name: | Multi-modality Workstation |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | Beijing Superlaser Technology Co., Ltd. No.2 Zhongfu Street, Economic And Technological Industrial Zone Xihongmen Town, 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 | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-13 |
| Decision Date | 2019-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973537442008 | K192519 | 000 |