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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K171404
Device Name BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
Applicant
Bausch + Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact Glenn A. Davies
Correspondent
Foresight Regulatory Strategies, Inc.
187 Ballardvale St.
Suite A 250
Wilmington,  MA  01887
Correspondent Contact Ellen M. Beucler
Regulation Number886.5916
Classification Product Code
HQD  
Date Received05/12/2017
Decision Date 07/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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