510(k) K842504

AMER. MEDICAL OPTICS DIGITAL KERATO- by American Medical Optics — Product Code HQL

K842504 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "AMER. MEDICAL OPTICS DIGITAL KERATO-". The FDA issued a decision of Substantially Equivalent on October 1, 1984. The device falls under product code HQL (Intraocular Lens), a Class III device regulated under 21 CFR 886.3600. American Medical Optics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1984
Date Received
June 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intraocular Lens
Device Class
Class III
Regulation Number
886.3600
Review Panel
OP
Submission Type