510(k) K844150

MEDICAL OPTICS PHACOEMULSIFICATION KIT by American Medical Optics — Product Code HQC

K844150 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "MEDICAL OPTICS PHACOEMULSIFICATION KIT". The FDA issued a decision of Substantially Equivalent on December 11, 1984. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. American Medical Optics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1984
Date Received
October 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type