Question 1

What types of medical devices does Shenzhen GSD Tech Co., Ltd. manufacture?

Accepted Answer

Shenzhen GSD Tech Co., Ltd. specializes in dermatological and cosmetic medical devices. Their portfolio includes diode laser systems for hair removal and skin treatments, carbon dioxide laser systems for precise tissue procedures, ultraviolet phototherapy units for professional medical use, and intense pulsed light (IPL) systems for skin surface treatments. These devices are designed for dermatology and cosmetology applications.

Question 2

Where is Shenzhen GSD Tech Co., Ltd. based?

Accepted Answer

The company is headquartered in Shenzhen, China. This location reflects its role as a manufacturer of advanced dermatological and cosmetic laser systems, catering to both domestic and international markets.

Question 3

Which regulatory registries list Shenzhen GSD Tech Co., Ltd.’s devices?

Accepted Answer

Shenzhen GSD Tech Co., Ltd.’s devices are listed in multiple regulatory databases, including the EU’s eudamed registry, the FDA’s 510(k) premarket notification system, and the FDA’s UDI (Unique Device Identification) database. These listings help ensure compliance and traceability for their Class II and Class IIa devices.

Question 4

How are Shenzhen GSD Tech Co., Ltd.’s devices classified under regulatory standards?

Accepted Answer

The company’s devices are primarily classified as Class II or Class IIa under regulatory frameworks. This classification is based on their intended use—such as laser hair removal, skin treatments, and phototherapy—which requires moderate levels of regulatory oversight to ensure safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
Gsd	GP666C4	FDA UDI	Class II	Active
Gsd	GP908D	FDA UDI	Class II	Active
Gsd	GP900A	FDA UDI	Class II	Active
Gsd	GP908B	FDA UDI	Class II	Active
Gsd	GP900Q	FDA UDI	Class II	Active
Gsd	GP900F	FDA UDI	Class II	Active
Gsd Intense Pulsed Light System, Models: Gp666c4, Gp666c	K091664	FDA 510(k)	Class II	Active
Diode Laser System GP900A8, Diode Laser System GP900Q8	K213225	FDA 510(k)	Class II	Active
Light Based Hair Removal Device GP592	K230060	FDA 510(k)	Class II	Active
Light based hair removal device	K180383	FDA 510(k)	Class II	Active
Diode Laser Hair Removal System	K142186	FDA 510(k)	Class II	Active
CO2 Laser System	K191518	FDA 510(k)	Class II	Active
308nm Excimer UV-light Skin Therapy System	K202827	FDA 510(k)	Class II	Active
Coolite Evo	GP900Q6	EUDAMED	Class IIa	Active
Coolite BOLT XS	GP900Q8	EUDAMEDFDA UDI	Class IIa	Active
Coolite BOLT	GP900A8	EUDAMEDFDA UDI	Class IIa	Active
Coolite Pro XL	GP900A3	EUDAMED	Class IIa	Active

Shenzhen GSD Tech Co., Ltd.

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