510(k) K053041

MED SCULPT by General Project S.R.L. — Product Code IMI

K053041 is an FDA 510(k) premarket notification submitted by General Project S.R.L. for the device "MED SCULPT". The FDA issued a decision of Substantially Equivalent on August 2, 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. General Project S.R.L. has at least 5 other 510(k) clearances on record.