510(k) K123710

UNITOX BOTOX SYRINGE by Bio-Med USA, Inc. — Product Code FMF

K123710 is an FDA 510(k) premarket notification submitted by Bio-Med USA, Inc. for the device "UNITOX BOTOX SYRINGE". The FDA issued a decision of Substantially Equivalent on May 9, 2013. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Bio-Med USA, Inc. has at least 10 other 510(k) clearances on record.