Enamel Pure
LUNE PureHygiene
SKU K260138UPC GEX
In Stock
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IIFDA 510(k) Cleared (K260138)
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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 (K260138) 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 May 28, 2026. Regulation: 8.
