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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K202932
Device Name ABT12 multi-purpose solution
Applicant
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact Melissa Thomas
Correspondent
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact Melissa Thomas
Regulation Number886.5928
Classification Product Code
LPN  
Date Received09/29/2020
Decision Date 05/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT03897751
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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