510(k) K160075

Accent XL by Alma Lasers, Inc. — Product Code IMI

K160075 is an FDA 510(k) premarket notification submitted by Alma Lasers, Inc. for the device "Accent XL". The FDA issued a decision of Substantially Equivalent on August 17, 2016. 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. Alma Lasers, Inc. has at least 10 other 510(k) clearances on record.