The following data is part of a premarket notification filed by Shanghai Wonderful Opto-electrics Tech. Co., Ltd. with the FDA for Matrix Ls-40 Co2 Laser System.
| Device ID | K161356 |
| 510k Number | K161356 |
| Device Name: | Matrix LS-40 CO2 Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD. 2F, BUILDING 3 LANE 561, NUJIANG ROAD (NORTH) Shanghai, CN 200333 |
| Contact | Amy Lee |
| Correspondent | Jonathan Hu MEDWHEAT (SHANGHAI) MEDICAL TECHNOLOGY CO., LTD. YANGPU DISTRIST 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 | 2016-05-16 |
| Decision Date | 2016-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972693080024 | K161356 | 000 |