510(k) K912112

PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 by Tomey Corporation USA — Product Code LQJ

K912112 is an FDA 510(k) premarket notification submitted by Tomey Corporation USA for the device "PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480". The FDA issued a decision of Substantially Equivalent on June 17, 1991. The device falls under product code LQJ (Lens, Surgical, Laser, Accesssory, Ophthalmic Laser), a Class II device regulated under 21 CFR 886.4390. Tomey Corporation USA has at least 8 other 510(k) clearances on record.