The following data is part of a premarket notification filed by Shanghai Wonderful Opto-electrics Tech. Co., Ltd with the FDA for 810nm Diode Laser System.
| Device ID | K183122 |
| 510k Number | K183122 |
| Device Name: | 810nm Diode Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Shanghai Wonderful Opto-Electrics Tech. Co., Ltd 2F, Building 9, Lane 561, Nujiang Road (North) Shanghai, CN 200333 |
| Contact | Yvonne Xue |
| Correspondent | Jonathan Hu Medwheat (Shanghai) Medical Technology Co., Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No.33 Room 303 Shanghai, CN 200093 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-09 |
| Decision Date | 2019-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972693080031 | K183122 | 000 |