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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 the device name listed in this FDA 510(k) record. The listed applicant is Ast Products, Inc.. It received FDA 510(k) clearance on 2020-06-04 under 510(k) 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. The listed applicant is Ast Products, Inc.. The 510(k) number is K200057.

When did bioli lOL Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for bioli lOL Delivery System?

The FDA 510(k) record lists Ast Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ast Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MSS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AGK242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, IncorporatedK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.

Official Source

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

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