Is Silhouette FDA Approved?

Yes, in 2007, the ARANZ Medical Silhouette system gained US Food and Drug Administration (FDA) approval as a Class I Medical Device (510k number K070426). It is classified as 21 CFR 878.4160 – surgical camera and accessories. Silhouette is one, of very few, wound cameras and assessment systems to gain FDA approval. This classification is now FDA exempt.

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