510(k) K930442

MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS by Marco Ophthalmic, Inc. — Product Code HKI

K930442 is an FDA 510(k) premarket notification submitted by Marco Ophthalmic, Inc. for the device "MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS". The FDA issued a decision of Substantially Equivalent on August 9, 1993. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Marco Ophthalmic, Inc. has at least 10 other 510(k) clearances on record.