510(k) K140336

OPTIMUS FUSION: SLT, YAG AND YAG/SLT by Quantel Medical — Product Code HQF

K140336 is an FDA 510(k) premarket notification submitted by Quantel Medical for the device "OPTIMUS FUSION: SLT, YAG AND YAG/SLT". The FDA issued a decision of Substantially Equivalent on June 25, 2014. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Quantel Medical has at least 10 other 510(k) clearances on record.