510(k) K082622

ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE by Alma Lasers , Ltd. — Product Code NUV

K082622 is an FDA 510(k) premarket notification submitted by Alma Lasers , Ltd. for the device "ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE". The FDA issued a decision of Substantially Equivalent on January 12, 2009. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810. Alma Lasers , Ltd. has at least 10 other 510(k) clearances on record.