The following data is part of a premarket notification filed by Shangdong Huamei Technology Co., Ltd. with the FDA for Co2 Laser Therapy System.
| Device ID | K192528 |
| 510k Number | K192528 |
| Device Name: | CO2 Laser Therapy System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Shangdong Huamei Technology Co., Ltd. No. 588, Changning Street, High-tech District Weifang, CN 261205 |
| Contact | Xu Qinghua |
| 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 | 2019-09-13 |
| Decision Date | 2019-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973512860216 | K192528 | 000 |