Atlas FDA

LPN

120 FDA 510(k) clearances · Product code

90 daysmedian time to decision
241 days90th percentile
120clearances measured

FDA profile

Official device name
Accessories, Soft Lens Products
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5928
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 51 · 2022: 62 · 2023: 84 · 2024: 80 · 2025: 47 · 2026: 58
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (K222541)Bausch & Lomb, Incorporated2022-12-06
Aqua Naina Plus Sterile Saline Solution (K221263)Chemtex USA, Inc.2022-10-12
ABT12 multi-purpose solution (K202932)Bausch & Lomb, Incorporated2021-05-28
OTE MPS 045 Multi-purpose Lens Care Solution (K210051)Ote North America, LLC2021-05-26
Aqua Naina Sterile Saline Solution (K193441)Chemtex USA, Inc.2020-05-26
PuriLens Plus Preservative Free Saline (K200747)The Lifestyle Company, Inc.2020-05-15
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (K191872)Menicon Co, Ltd.2020-03-02
REFRESH RELIEVA For CONTACTS (K190674)Allergan, Inc.2019-08-08
AOCup Lens Case with AODisc (K191795)Alcon Laboratories, Inc.2019-07-31
Bausch + Lomb Sensitive Eyes Plus Saline Solution (K170483)Bausch & Lomb, Incorporated2017-04-11
NNR06 Multi-Purpose Solution (K161819)Bausch & Lomb, Incorporated2016-11-25
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (K162597)Alcon Laboratories, Inc.2016-10-19
LensGiene Sterile Saline Solution (K161622)Optics Laboratory, Inc.2016-08-11
Menicon Saline Rinse Solution (K151768)Menicon Co, Ltd.2015-08-28
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE (K142284)Alcon Laboratories, Inc.2015-01-26
BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION (K132216)Bausch & Lomb, Incorporated2013-09-09
SAUFLON MULTIPURPOSE SOLUTION (K130734)Sauflon Pharmaceuticals, Ltd.2013-05-15
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION (K112909)Bausch & Lomb, Inc.2012-04-30
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION (K111877)Bausch & Lomb, Inc.2012-01-24
EYE-CEPT STERILE SALINE SOLUTION (K110221)Optics Laboratory, Inc.2011-11-01
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION (K102860)Alcon Research, Ltd.2011-05-10
STERILE SALINE SOLUTION (K102165)Cachet Pharmaceuticals Pvt. , Ltd.2011-01-19
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION (K093254)Abbott Medical Optics, Inc.2010-09-15
STERILE SALINE SOLUTION (K093367)Cachet Pharmaceuticals Pvt. , Ltd.2010-09-10
REFRESH OPTIVE LENS COMFORT REWETTING DROPS (K083812)Allergan, Inc.2009-07-09
ALCON MULTI-PURPOSE SOLUTION (K071236)Alcon, Inc.2007-12-12
EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION (K070767)Lapis Lazuli International NV2007-07-24
SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES (K071203)Optikem International, Inc.2007-06-13
ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION (K062332)Altaire Pharmaceuticals, Inc.2007-04-25
JSZ MULTIACTION GP CONTACT LENS SOLUTION (K060924)Szabocsik and Associates2006-06-28
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION (K051104)Lapis Lazuli, NV2006-05-31
ALCON MULTI-PURPOSE DISINFECTING SOLUTION (K050729)Alcon Research, Ltd.2005-09-14
AQUIFY MULTIPURPOSE SOLUTION (K050250)Ciba Vision Corporation2005-08-10
LENS PLUS REWETTING DROPS (K042562)Advanced Medical Optics, Inc.2005-07-29
EYE-CEPT REWETTING DROPS (K041008)Optics Laboratory, Inc.2005-07-01
JSZ-MULTIPURPOSE SOLUTION (K050517)Szabocsik and Associates2005-04-13
AQUIFY LENS COMFORT DROPS (K042176)Ciba Vision Corporation2004-11-03
KARATS MULTIPURPOSE SOLUTION (K031753)Ciba Vision Corporation2004-10-28
AQUIFY MULTI-PURPOSE SOLUTION (K033608)Ciba Vision Corporation2004-02-02
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 (K031646)Bausch & Lomb, Inc.2003-11-14
THERATEARS CONTACT LENS COMFORT DROPS (K032481)Advanced Vision Research, Inc.2003-11-04
CLUED UP MULTIPURPOSE SOLUTION- NO RUB (K030910)Clued UP Limited2003-10-10
BLINK CL LUBRICANT EYE DROPS (K032030)Advanced Medical Optics, Inc.2003-09-25
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K030522)Ciba Vision Corporation2003-09-12
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION (K031957)Ciba Vision Corporation2003-08-14
SAUFLON MULTIPURPOSE SOLUTION - NO RUB (K030278)Sauflon Pharmaceuticals, Ltd.2003-07-30
SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION (K031193)Alcon, Inc.2003-07-03
SOLO-CARE PLUS MULTIPURPOSE SOLUTION (K031522)Ciba Vision Corporation2003-06-27
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K031521)Ciba Vision Corporation2003-06-27
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K030092)Advanced Medical Optics, Inc.2003-04-04
KARATS MULTIPURPOSE SOLUTION (K021635)Ciba Vision Corporation2002-10-28
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION (K021143)Alcon Universal, Ltd.2002-08-08
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K014202)Allergan, Inc.2002-02-20
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K013479)Allergan, Inc.2002-02-11
SOLO-CARE PLUS MULTIPURPOSE SOLUTION (K012731)Ciba Vision Corporation2001-12-26
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K013512)Ciba Vision Corporation2001-12-20
SAUFLON MULTI LENS CARE SYSTEM (K010559)Sauflon Pharmaceuticals, Ltd.2001-12-20
SEREINE EXTRA STRENGTH DAILY CLEANER (K011561)Wilsa, Inc.2001-11-20
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION (K011796)Bausch & Lomb, Inc.2001-11-01
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION (K003345)Ciba Vision Corporation2001-03-26
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K003252)Allergan, Inc.2001-02-21
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML (K003031)Alpha Vista, Inc.2001-01-05
COMPLETE BRAND LUBRICATING AND REWETTING DROPS (K003109)Allergan, Inc.2000-11-21
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION (K002589)Alcon Universal, Ltd.2000-10-23
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION (K002823)Bausch & Lomb, Inc.2000-10-17
PURILENS SALINE SOLUTION (K002319)Purilens, Inc.2000-08-30
RENU MULTIPLUS MULTI-PURPOSE SOLUTION (K001539)Bausch & Lomb, Inc.2000-07-31
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION (K001214)Alcon Universal, Ltd.2000-07-10
OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES (K000998)Optisonic, Inc.2000-06-05
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION (K000164)Allergan, Inc.2000-06-02
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER (K000247)Bausch & Lomb, Inc.2000-04-20
REFRESH CONTACTS LUBRICATING AND REWETTING DROPS (K992028)Allergan, Inc.1999-10-07
VISINE FOR CONTACTS (K991620)Pfizer, Inc.1999-09-24
OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP (K984573)Alcon Laboratories1999-09-16
SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES (K991125)Sauflon Pharmaceuticals, Ltd.1999-09-14
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION (K991403)Ciba Vision Corporation1999-07-16
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (K990480)Alcon Laboratories1999-05-10
RENU MULTIPLUS MULTI-PURPOSE SOLUTION (K990422)Bausch & Lomb, Inc.1999-04-27
BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER (K983225)Bausch & Lomb, Inc.1999-03-29
LOBOB UNIVERSAL CONTACT LENS CLEANER (K990044)Lobob Laboratories, Inc.1999-02-11
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K984575)Alcon Laboratories1999-01-14
OPTI-ONE MULTI-PURPOSE SOLUTION (K983973)Alcon Laboratories1998-12-18
ULTRACARE NEUTRALIZING TABLETS (K984383)Allergan, Inc.1998-12-18
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K983780)Alcon Laboratories1998-12-18
COMPLETE BRAND LUBRICATING AND REWETTING DROPS (K983150)Allergan, Inc.1998-11-25
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION (K982168)Ciba Vision Corporation1998-11-17
BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION (K982775)Bausch & Lomb, Inc.1998-11-03
COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS (K981168)Allergan, Inc.1998-09-01
LIQUID ENZYME ID 90133 (K981561)Alcon Laboratories1998-07-24
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K980775)Allergan, Inc.1998-07-06
OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION (K981574)Alcon1998-07-06
RENU MULTIPLUS LUBRICATING & REWETTING DROPS (K980591)Bausch & Lomb, Inc.1998-06-24
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392 (K981151)Alcon Laboratories1998-06-22
YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION (K980147)Automatic Liquid Packaging, Inc.1998-04-13
BAUSCH & LOMB WETTING AND SOAKING SOLUTION (K980133)Polymer Technology Corp.1998-03-11
RENU MULTIPLUS MULTI-PURPOSE SOLUTION (K974723)Bausch & Lomb, Inc.1998-03-10
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (K974625)Alcon Laboratories1998-03-04
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K974624)Alcon Laboratories1998-03-04
SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION (K974485)Szabocsik and Assoc.1998-02-24
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION (K973921)Bausch & Lomb, Inc.1998-01-12
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