Atlas FDA

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

FDA 510(k) clearance K210300 · decided 2021-04-01

Clearance details

K-number
K210300
Device name
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
Applicant
Vuesonic, LLC
Decision
Substantially Equivalent
Date received
2021-02-03
Decision date
2021-04-01
Days to decision
57 days
Clearance type
Traditional
Product code
LYL
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Miami Beach, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
3N Contact Lenses Adjunct Cleaner (K211361)Suzhou 3N Biological Technology Co., Ltd.2022-01-13
BPZ02 MULTIPURPOSE SOLUTION (K083757)Bausch & Lomb, Inc.2009-11-18
AUTOLENS CLEANING AND DISINFECTING UNIT (K021699)Autolens, Inc.2002-12-16
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K022687)Ciba Vision Corporation2002-11-19
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (K020802)Bausch & Lomb, Incorporated2002-05-31
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION (K994021)Strieter Clinical Research Laboratories, Inc.2000-02-22
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES (K991965)Purilens, Inc.1999-10-01
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY (K982115)Rim-Wide Companies, Inc.1999-01-13
SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT (K974724)Lens Comfort, Inc.1998-03-02
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (K964222)Paladin Medical, Inc.1996-12-20
NEW COMFORT CONTACT LENS CARE ACCESSORY (K962112)Lens Comfort, Inc.1996-11-29
OPTI PADS (K950940)Karlen Mfg., Inc.1995-06-26

Recalls involving this device

No recalls on record reference this clearance.