The following data is part of a premarket notification filed by Shanghai Apolo Medical Technology Co., Ltd. with the FDA for Ipl Treatment Systems.
| Device ID | K200746 |
| 510k Number | K200746 |
| Device Name: | IPL Treatment Systems |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District Shanghai, CN 200231 |
| Contact | Felix Li |
| Correspondent | Felix Li Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District Shanghai, CN 200231 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-23 |
| Decision Date | 2020-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970745916604 | K200746 | 000 |
| 06970745916512 | K200746 | 000 |
| 06970745916208 | K200746 | 000 |
| 06970745913108 | K200746 | 000 |
| 06970745913016 | K200746 | 000 |