The following data is part of a premarket notification filed by Shenzhen Gsd Tech Co., Ltd. with the FDA for Diode Laser System Gp900a8, Diode Laser System Gp900q8.
| Device ID | K213225 |
| 510k Number | K213225 |
| Device Name: | Diode Laser System GP900A8, Diode Laser System GP900Q8 |
| 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 | Huifang Yao |
| Correspondent | Huifang Yao Shenzhen GSD Tech Co., Ltd. Building A, JUNSD Hi-Tech Park, West Of Bao’An RD. Watch & Clock Base, Guangming District Shenzhen, CN 518106 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2021-12-22 |