The following data is part of a premarket notification filed by Shanghai Apolo Medical Technology Co., Ltd. with the FDA for Platform Treatment System.
| Device ID | K203395 |
| 510k Number | K203395 |
| Device Name: | Platform Treatment System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Shanghai Apolo Medical Technology Co., Ltd. Room 301-310, Building 11, No.388, Yindu Road, Xuhui District Shanghai, CN 200231 |
| Contact | Felix Li |
| Correspondent | Felix Li Shanghai Apolo Medical Technology Co., Ltd. Room 301-310, Building 11, No.388, Yindu Road, Xuhui District Shanghai, CN 200231 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-18 |
| Decision Date | 2022-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970745919001 | K203395 | 000 |