510(k) K172228

pioli IOL Delivery System by Ast Products, Inc. — Product Code MSS

K172228 is an FDA 510(k) premarket notification submitted by Ast Products, Inc. for the device "pioli IOL Delivery System". The FDA issued a decision of Substantially Equivalent on December 15, 2017. 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
December 15, 2017
Date Received
July 25, 2017
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