Cleared Traditional

bioli lOL Delivery System

K200057 · Ast Products, Inc. · Ophthalmic

Jun 2020

Decision

143d

Days

Class 1

Risk

About This 510(k) Submission

K200057 is an FDA 510(k) clearance for the bioli lOL 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 June 4, 2020, 143 days after receiving the submission on January 13, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number	K200057 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2020
Decision Date	June 04, 2020
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF