510(k) K081946

SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR by Quantel Medical — Product Code HQF

K081946 is an FDA 510(k) premarket notification submitted by Quantel Medical for the device "SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR". The FDA issued a decision of Substantially Equivalent on March 25, 2009. 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.