Enamel Pure
LUNE PureHygiene
SKU K234085UPC GEX
In Stock
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IIFDA 510(k) Cleared (K234085)
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Free shipping on orders over $99 · 30-day returns
Enamel Pure
Free shipping on orders over $99 · 30-day returns
LUNE PureHygiene is an FDA 510(k)-cleared medical device (K234085) manufactured by Enamel Pure. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 24, 2024. Regulation: 8.
