The following data is part of a premarket notification filed by Shangdong Huamei Technology Co., Ltd. with the FDA for Intense Pulsed Light Treatment System.
| Device ID | K192521 |
| 510k Number | K192521 |
| Device Name: | Intense Pulsed Light Treatment System |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| 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 | 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 | 2019-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973512860025 | K192521 | 000 |
| 06973512860018 | K192521 | 000 |
| 06973512860049 | K192521 | 000 |
| 06973512860032 | K192521 | 000 |