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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Folders And Injectors, Intraocular Lens (Iol)
510(k) Number K192005
Device Name Bausch + Lomb PreVue Inserter for enVista Preloaded
Applicant
Bausch & Lomb, Inc.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact Rekha Janarthanan
Correspondent
Bausch & Lomb, Inc.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact Rekha Janarthanan
Regulation Number886.4300
Classification Product Code
MSS  
Date Received07/29/2019
Decision Date 10/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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