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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Solution, Ultrasonic Cleaners For Lenses
510(k) Number K210300
Device Name VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
Applicant
Vuesonic, LLC
1234 Washington Ave., #205
Miami Beach,  FL  33139
Applicant Contact Sheri Ker
Correspondent
Contract In-House Counsel and Consultants,Llc (D/B/A FDA Att
1717 Pennsylvania Ave. NW, Suite 1025
Washington Dc,  DC  20006
Correspondent Contact Marc C. Sanchez
Regulation Number886.5928
Classification Product Code
LYL  
Date Received02/03/2021
Decision Date 04/01/2021
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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