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FDA 510(k)

Bausch + Lomb PreVue Inserter for enVista Preloaded

K-Number: K192005 · 2019-10-04

ApplicantBausch & Lomb, Inc.
Decision Date2019-10-04
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Bausch + Lomb PreVue Inserter for enVista Preloaded is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K192005. 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 Bausch + Lomb PreVue Inserter for enVista Preloaded?

Bausch + Lomb PreVue Inserter for enVista Preloaded is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K192005.

When did Bausch + Lomb PreVue Inserter for enVista Preloaded receive FDA 510(k) clearance?

Bausch + Lomb PreVue Inserter for enVista Preloaded received FDA 510(k) clearance on 2019-10-04, under 510(k) number K192005.

Who is the listed applicant for Bausch + Lomb PreVue Inserter for enVista Preloaded?

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

What is the FDA product code for Bausch + Lomb PreVue Inserter for enVista Preloaded?

The FDA product code for Bausch + Lomb PreVue Inserter for enVista Preloaded is MSS.

Related Clinical Trials

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.

NCT06333015Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract ExtractionCOMPLETEDNCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETEDNCT07696130Evaluation of Visual Outcomes, Complications, and Neuroadaptation Following Bilateral Implantation of enVista Envy Trifocal Intraocular LensesRECRUITINGNCT05129488Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Biotrue ONEday Contact LensesCOMPLETEDNCT053259311-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for PresbyopiaCOMPLETEDNCT060537361-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact LensesCOMPLETED

Other records listing Bausch & Lomb, 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.

PMA P240005Lens, multifocal intraocularPMA P910056intraocular lensPMA P910071Fluid, intraocularPMA P860022Lens, contact (rigid gas permeable), extended wearPMA P010062Lens, contact, orthokeratology, overnightPMA N16895Lenses, soft contact, extended wear

View all 38 devices →

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

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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