
Coloplast Corp.
Free shipping on orders over $99 · 30-day returns
AMOENA BREAST FORMS is an FDA 510(k)-cleared medical device (K853822) manufactured by Coloplast Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 29, 1985. Regulation: 8.