VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

Accessories, Solution, Ultrasonic Cleaners For Lenses

VueSonic, LLC

The following data is part of a premarket notification filed by Vuesonic, Llc with the FDA for Vuesonic One Contact Lens Cleaning System, Vuesonic Advance 2 Contact Lens Cleaning System.

Pre-market Notification Details

Device IDK210300
510k NumberK210300
Device Name:VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
ClassificationAccessories, Solution, Ultrasonic Cleaners For Lenses
Applicant VueSonic, LLC 1234 Washington Ave., #205 Miami Beach,  FL  33139
ContactSheri Ker
CorrespondentMarc C. Sanchez
Contract In-House Counsel And Consultants,LLC (d/b/a FDA Att 1717 Pennsylvania Ave. NW, Suite #1025 Washington,  DC  20006
Product CodeLYL  
CFR Regulation Number886.5928 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-03
Decision Date2021-04-01

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