Cleared Traditional

pioli IOL Delivery System

K172228 · Ast Products, Inc. · Ophthalmic

Dec 2017

Decision

143d

Days

Class 1

Risk

About This 510(k) Submission

K172228 is an FDA 510(k) clearance for the pioli IOL Delivery System, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Ast Products, Inc. (Billerica, US). The FDA issued a Cleared decision on December 15, 2017, 143 days after receiving the submission on July 25, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number	K172228 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2017
Decision Date	December 15, 2017
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF