The following data is part of a premarket notification filed by Shanghai Apolo Medical Technology Co., Ltd. with the FDA for 980nm Diode Laser Therapy Device.
| Device ID | K191349 |
| 510k Number | K191349 |
| Device Name: | 980nm Diode Laser Therapy Device |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District Shanghai, CN 200231 |
| Contact | Felix Li |
| Correspondent | Claire Zhang Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705 , Building 1, West Guangzhong Road 555, Jingan District Shanghai, CN 200071 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-20 |
| Decision Date | 2019-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970745918905 | K191349 | 000 |