510(k) K101147

MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM by Alma Lasers, Inc. — Product Code NUV

K101147 is an FDA 510(k) premarket notification submitted by Alma Lasers, Inc. for the device "MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM". The FDA issued a decision of Substantially Equivalent on January 21, 2011. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810. Alma Lasers, Inc. has at least 10 other 510(k) clearances on record.