The following data is part of a premarket notification filed by Beijing Stelle Laser Technology Co., Ltd. with the FDA for Dermatological Diode Laser System.
| Device ID | K212478 |
| 510k Number | K212478 |
| Device Name: | Dermatological Diode Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Beijing Stelle Laser Technology Co., Ltd. Rm.502-1, Tower B, Building 1, Yard 26, Zhongguancun Medical Device Park, Yongwang West Rd. Beijing, CN 102600 |
| Contact | Zhao Changcheng |
| 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 | 2021-08-09 |
| Decision Date | 2022-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007876813 | K212478 | 000 |
| 00860007876837 | K212478 | 000 |