The following data is part of a premarket notification filed by Shanghai Apolo Medical Technology Co., Ltd. with the FDA for Diode Laser Body Sculpture System.
| Device ID | K201731 |
| 510k Number | K201731 |
| Device Name: | Diode Laser Body Sculpture System |
| Classification | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| 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 | PKT |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-24 |
| Decision Date | 2020-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970745918516 | K201731 | 000 |