510(k) K842128

AMERICAN MEDICAL OPTICS PHOTOKERATO by American Medical Optics — Product Code HJA

K842128 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "AMERICAN MEDICAL OPTICS PHOTOKERATO". The FDA issued a decision of Substantially Equivalent on August 7, 1984. The device falls under product code HJA (Photokeratoscope), a Class I device regulated under 21 CFR 886.1350. American Medical Optics has at least 10 other 510(k) clearances on record.