Brillenerzeugung Pomberger

Brillenerzeugung Pomberger specializes in custom spectacle frames and sunglasses. These products are designed for optical and protective eyewear applications, including general-use frames and sunglasses. Their offerings are tailored to meet specific customer needs within these categories.

Brillenerzeugung Pomberger is based in the United States. While the company’s headquarters and operations are located there, the specific manufacturing locations for their devices are not detailed in the provided information.

Brillenerzeugung Pomberger’s devices, including spectacle frames and sunglasses, are classified as Class I medical devices under FDA regulations. This classification applies because these products pose minimal risk and are generally considered safe and effective for their intended use without active controls or special controls.

Yes, Brillenerzeugung Pomberger’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class I devices that are substantially equivalent to legally marketed predicates, ensuring compliance with FDA requirements for medical devices.

The classification of Brillenerzeugung Pomberger’s devices as Class I is based on their intended use and risk profile. Spectacle frames and sunglasses are generally considered low-risk medical devices because they do not require active controls or special monitoring to ensure safety and performance. The FDA categorizes them under Class I due to their minimal risk to users.