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Frequently Asked Questions VASERshape is a Food and Drug Administration (FDA) approved system, which uses two hand-held units to combine ultrasound technology and zonal massage

Why This Matters: A Quick Primer on Section 503A Under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), human drug products compounded by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician can be exempt from three major FDA requirements: current Good Manufacturing Practice (cGMP) standards, certain labeling requirements, and the standard new drug approval process (NDAs/ANDAs)

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Early real-world data suggest promising results in post-bariatric patients, though formal trials are limited

Packaged in a controlled laboratory environment and prepared for research-use applications