510(k) K863048

OPM SLIT LAMP MODEL P-1 & MODEL P-3 by Optek Medico Co., Ltd. — Product Code HJO

K863048 is an FDA 510(k) premarket notification submitted by Optek Medico Co., Ltd. for the device "OPM SLIT LAMP MODEL P-1 & MODEL P-3". The FDA issued a decision of Substantially Equivalent on September 3, 1986. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Optek Medico Co., Ltd. has at least 2 other 510(k) clearances on record.