FDA 510(k) Applications for Medical Device Product Code "LYL"
(Accessories, Solution, Ultrasonic Cleaners For Lenses)

FDA 510(k) Number Applicant Device Name Decision Date
K021699 AUTOLENS INC. AUTOLENS CLEANING AND DISINFECTING UNIT 12/16/2002
K020802 BAUSCH & LOMB INCORPORATED RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION 05/31/2002
K083757 BAUSCH & LOMB, INC. BPZ02 MULTIPURPOSE SOLUTION 11/18/2009
K022687 CIBA VISION CORPORATION AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION 11/19/2002
K962112 LENS COMFORT, INC. NEW COMFORT CONTACT LENS CARE ACCESSORY 11/29/1996
K974724 LENS COMFORT, INC. SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT 03/02/1998
K964222 PALADIN MEDICAL, INC. ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING 12/20/1996
K991965 PURILENS, INC. PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES 10/01/1999
K982115 RIM-WIDE COMPANIES, INC. LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY 01/13/1999
K994021 STRIETER CLINICAL RESEARCH LABORATORIES, INC. CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION 02/22/2000
K211361 Suzhou 3N Biological Technology Co., Ltd 3N Contact Lenses Adjunct Cleaner 01/13/2022
K210300 VueSonic, LLC VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System 04/01/2021


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