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FDA 510(k)

EyeGility™ Inserter for Preloaded enVista IOLs

K-Number: K242389 · 2024-10-10

ApplicantBausch & Lomb, Incorporated
Decision Date2024-10-10
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EyeGility™ Inserter for Preloaded enVista IOLs is a medical device manufactured by Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2024-10-10 under approval number K242389. 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 EyeGility™ Inserter for Preloaded enVista IOLs?

EyeGility™ Inserter for Preloaded enVista IOLs is a medical device that received FDA 510(k) clearance on 2024-10-10. It is manufactured by Bausch & Lomb, Incorporated. The 510(k) number is K242389.

When was EyeGility™ Inserter for Preloaded enVista IOLs approved by the FDA?

EyeGility™ Inserter for Preloaded enVista IOLs received FDA 510(k) clearance on 2024-10-10, under approval number K242389.

What company makes EyeGility™ Inserter for Preloaded enVista IOLs?

EyeGility™ Inserter for Preloaded enVista IOLs is manufactured by Bausch & Lomb, Incorporated.

What is the FDA product code for EyeGility™ Inserter for Preloaded enVista IOLs?

The FDA product code for EyeGility™ Inserter for Preloaded enVista IOLs is MSS.

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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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