Data / Medical devices / China / Shenzhen GSD Tech Co., Ltd
Shenzhen GSD Tech Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 7 510(k) clearances
Shenzhen GSD Tech Co., Ltd is registered with the FDA (registration 3006580954) in Shenzhen Guangdong, China. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006580954
- Address
- Building A, JUNSD Hi-Tech Park, Watch & Clock Base, Guangming District, Shenzhen Guangdong, China, 518106
- Owner or operator
- Shenzhen GSD Tech Co., Ltd (10031346)
- Roles
- Manufacturer
- First device listed
- January 19, 2010
- Registered through
- 2026
- Brand names listed
- 308nm Excimer UV-Light Skin Therapy System GP908B, 308nm Excimer UV-Light Skin Therapy System GP908D, DEESS, DIODE LASER HAIR REMOVAL SYSTEM GP900A, DIODE LASER HAIR REMOVAL SYSTEM GP900Q, DIODE LASER SYSTEM GP900Q6, DermaTeller, Diode Laser System GP900A8 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Manufacturer | accessdata.fda.gov |
| Light, Microscope | IBJ | 1 | Manufacturer | accessdata.fda.gov |
| Light, Ultraviolet, Dermatological | FTC | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 3, 2023 | K230060 | Light Based Hair Removal Device GP592 | OHT | Substantially Equivalent | Shenzhen Gsd Tech Co., Ltd. | accessdata.fda.gov |
| December 22, 2021 | K213225 | Diode Laser System GP900A8, Diode Laser System GP900Q8 | GEX | Substantially Equivalent | Shenzhen Gsd Tech Co., Ltd. | accessdata.fda.gov |
| December 15, 2020 | K202827 | 308nm Excimer UV-light Skin Therapy System | FTC | Substantially Equivalent | Shenzhen Gsd Tech Co., Ltd. | accessdata.fda.gov |
| September 12, 2019 | K191518 | CO2 Laser System | GEX | Substantially Equivalent | Shenzhen Gsd Tech Co., Ltd. | accessdata.fda.gov |
| May 11, 2018 | K180383 | Light based hair removal device | OHT | Substantially Equivalent | Shenzhen Gsd Tech Co., Ltd. | accessdata.fda.gov |
| April 17, 2015 | K142186 | DIODE LASER HAIR REMOVAL SYSTEM | GEX | Substantially Equivalent | Shenzhen Gsd Tech Co., Ltd. | accessdata.fda.gov |
| November 16, 2009 | K091664 | GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C | ONF | Substantially Equivalent | Shenzhen Gsd Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Light, Ultraviolet, Dermatological
- All makers of Light Based Over-The-Counter Hair Removal
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Light, Microscope
Updated March 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.