510(k) K142056

LIOLI IOL DELIVERY SYSTEM by Ast Products, Inc. — Product Code MSS

K142056 is an FDA 510(k) premarket notification submitted by Ast Products, Inc. for the device "LIOLI IOL DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 9, 2015. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Ast Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2015
Date Received
July 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Folders And Injectors, Intraocular Lens (Iol)
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type