510(k) K052934

DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM by S.O.R. Internacional, S.A. — Product Code IMI

K052934 is an FDA 510(k) premarket notification submitted by S.O.R. Internacional, S.A. for the device "DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 12, 2006. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300.