Uvision360, Inc.
LUMINELLE DTx System
SKU K210512UPC FAJ
In Stock
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IIFDA 510(k) Cleared (K210512)
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Free shipping on orders over $99 · 30-day returns
Uvision360, Inc.
Free shipping on orders over $99 · 30-day returns
LUMINELLE DTx System is an FDA 510(k)-cleared medical device (K210512) manufactured by Uvision360, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 29, 2021. Regulation: 8.
