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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06928258000853 | K213225 | 000 |
06928258000846 | K213225 | 000 |