The following data is part of a premarket notification filed by Shenzhen Gsd Tech Co., Ltd with the FDA for Co2 Laser System.
| Device ID | K191518 |
| 510k Number | K191518 |
| Device Name: | CO2 Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Shenzhen GSD Tech Co., Ltd Building A Junsd Hi-Tech Park, West Of Bao'an Rd Watch & Clock Base, Guangming District Shenzhen, CN 518106 |
| Contact | Jiancheng Zhang |
| Correspondent | Becky Chen Feiying Drug & Medical Consulting Technical Service Group B-3F 3005, Bldg.1, Southward Ruifeng Business Center, No. 22 Guimiao Rd. Shenzhen, CN 518000 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-07 |
| Decision Date | 2019-09-12 |
| Summary: | summary |