The following data is part of a premarket notification filed by Wingderm Electro-optics Ltd. with the FDA for Diode Laser Therapy Systems.
| Device ID | K191611 |
| 510k Number | K191611 |
| Device Name: | Diode Laser Therapy Systems |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Wingderm Electro-Optics Ltd. Room 312, Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road Beijing, CN 100192 |
| Contact | Juan Zhou |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Service Co., Ltd 8-9th Floor, R&D Building, No.26 Qinglan Street Panyu District Guangzhou, CN 510006 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-17 |
| Decision Date | 2019-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972590500014 | K191611 | 000 |
| 16972590500028 | K191611 | 000 |
| 06972590500021 | K191611 | 000 |
| 06972978060024 | K191611 | 000 |
| 06972978060017 | K191611 | 000 |