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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 the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2024-10-10 under 510(k) 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. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K242389.

When did EyeGility™ Inserter for Preloaded enVista IOLs receive FDA 510(k) clearance?

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

Who is the listed applicant for EyeGility™ Inserter for Preloaded enVista IOLs?

The FDA 510(k) record lists Bausch & Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Bausch & Lomb, Incorporated 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 AGK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.K212039CLAREON MONARCH IV IOL Delivery SystemAlcon Laboratories, 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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