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FDA 510(k)

bioli lOL Delivery System

K-Number: K200057 · 2020-06-04

ApplicantAst Products, Inc.
Decision Date2020-06-04
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

bioli lOL Delivery System is a medical device manufactured by Ast Products, Inc.. It received FDA 510(k) clearance on 2020-06-04 under approval number K200057. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the bioli lOL Delivery System?

bioli lOL Delivery System is a medical device that received FDA 510(k) clearance on 2020-06-04. It is manufactured by Ast Products, Inc.. The 510(k) number is K200057.

When was bioli lOL Delivery System approved by the FDA?

bioli lOL Delivery System received FDA 510(k) clearance on 2020-06-04, under approval number K200057.

What company makes bioli lOL Delivery System?

bioli lOL Delivery System is manufactured by Ast Products, Inc..

What is the FDA product code for bioli lOL Delivery System?

The FDA product code for bioli lOL Delivery System is MSS.

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Other Devices by Ast Products, Inc.

K172228pioli IOL Delivery System K182965BL-Cart IOL Delivery Cartridge

Related Devices (Code: MSS)

K161776Lenstec LC Injection systemLenstec, Inc. K161012Easy-Load Lens Delivery SystemBausch and Lomb, Inc., K172228pioli IOL Delivery SystemAst Products, Inc. K173480Crystalsert Lens Delivery SystemBausch & Lomb, Inc. K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company K181401RxSight Insertion DeviceRxsight, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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