Light, Surgical, Carrier

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Guangdong and Shandong: 2 hold an FDA registration. 2 are contract manufacturers.

Shandong Weigao Orthopaedic Device Co., Ltd. Shandong, contract manufacturer
Shenzhen Kaiyan Medical Equipment Co., Ltd. Guangdong, contract manufacturer

What Is FDA Product Code FSZ?

Light, Surgical, Carrier is FDA product code FSZ, Class 2, 21 CFR 878.4580.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Light, Surgical, Carrier

PhotonGuide Adapt

Adapt Illuminator

Light, Surgical, Carrier

PhotonGuide Adapt

The PhotonGuide Adapt is intended to provide surgical site illumination from a high intensity light source.

Light, Surgical, Carrier

Illumin SYS 9560668 Strght-TIP Radiance

Light, Surgical, Carrier

PhotonGuide

The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.

Light, Surgical, Carrier

PhotonGuide

Illuminator, Narrow/Flat

Light, Surgical, Carrier

TracLux

TRACLUX Light Carrier, Sterile, Single Use, and accessories

Light, Surgical, Carrier

Which Manufacturers in China Make This?

What Is FDA Product Code FSZ?

How Does It Reach the US Market?

PhotonGuide Adapt

PhotonGuide Adapt