510(k) K823222

INTRAOCULAR LENS GUIDE by American Medical Optics — Product Code KYB

K823222 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "INTRAOCULAR LENS GUIDE". The FDA issued a decision of Substantially Equivalent on December 28, 1982. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. American Medical Optics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1982
Date Received
October 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type