Atlas FDA

LPL

486 FDA 510(k) clearances · Product code

85 daysmedian time to decision
251 days90th percentile
486clearances measured

FDA profile

Official device name
Lenses, Soft Contact, Daily Wear
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5925
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 110 · 2022: 126 · 2023: 178 · 2024: 297 · 2025: 217 · 2026: 132
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus (K260507)INTEROJO, Inc.2026-05-29
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses (K253352)Pegavision Corporation2026-05-21
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K261299)Pegavision Corporation2026-05-19
PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES (K253885)GEO MEDICAL CO., LTD.2026-04-29
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (K254269)St. shine Optical Co., Ltd.2026-03-19
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K252385)Pegavision Corporation2026-03-13
DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (K254052)Alcon Laboratories, Inc.2026-02-13
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) (K251683)Bruno Vision Care, LLC2025-12-23
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (K250364)St. shine Optical Co., Ltd.2025-10-07
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) (K244009)Yung Sheng Optical Co., Ltd.2025-09-25
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (K251095)Pegavision Corporation2025-09-17
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (K251573)Vizionfocus, Inc.2025-09-10
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (K242855)E.O.S Co., Ltd.2025-07-30
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K243868)Pegavision Corporation2025-07-02
miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus (K242056)Benq Materials Corporation2025-04-17
Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (K243953)Vizionfocus, Inc.2025-04-10
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) (K241884)Hunan Haipuming Technology Co., Ltd.2025-03-20
Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens (K242916)Largan Medical Co., Ltd.2025-02-04
Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric (K243909)Alcon Laboratories, Inc.2025-01-13
VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens (K242413)Vizionfocus, Inc.2024-12-17
Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K232839)Yung Sheng Optical Co., Ltd.2024-12-16
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism (K240918)Bruno Vision Care, LLC2024-10-25
Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens (K242391)Lucens Technology Co., Ltd.2024-10-08
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) (K242059)X-Cel Specialty Contacts, A Walman Optical Company2024-08-14
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ (K241707)Unicon Optical Co., Ltd.2024-07-12
Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (K240477)St. shine Optical Co., Ltd.2024-07-01
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (K232649)Pegavision Corporation2024-05-08
Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens (K240519)Innova Vision, Inc.2024-04-17
Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (K233221)Metro Optics of Austin, Inc.2024-02-06
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker (K234127)CooperVision, Inc.2024-01-25
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens (K223397)Hoya Lamphun , Ltd.2024-01-03
Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856)Alcon Laboratories, Inc.2023-12-29
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (K223585)Yung Sheng Optical Co., Ltd.2023-12-20
Samfilcon B Custom Contact Lens (K230954)Bausch + Lomb, Incorporated2023-11-17
DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric (K232921)Alcon Laboratories, Inc.2023-11-16
Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens (K232139)Innova Vision, Inc.2023-11-16
IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (K230824)Art Optical Contact Lens, Inc.2023-09-06
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (K222885)Pegavision Corporation2023-05-31
Precision1, Precision1 for Astigmatism (K230785)Alcon Laboratories, Inc.2023-04-20
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (K222954)Innova Vision, Inc.2023-03-13
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (K220613)Bausch & Lomb, Incorporated2023-03-08
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens (K221517)INTEROJO, Inc.2022-10-04
AIR OPTIX COLORS (K222500)Alcon Laboratories, Inc.2022-09-15
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens (K220143)Shenzhen Dashicheng Optical Technology Co., Ltd.2022-09-08
Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear (K213983)Yung Sheng Optical Co., Ltd.2022-09-02
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (K220045)Dk Medivision Co., Ltd.2022-08-05
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K213119)Innova Vision, Inc.2022-05-13
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (K220070)CooperVision, Inc.2022-02-04
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses (K211603)Pegavision Corporation2022-02-02
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens (K213216)Unicon Optical Co., Ltd.2022-01-18
Alcon (serafilcon A) soft contact lenses for daily wear (K212806)Alcon Laboratories, Inc.2021-12-28
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses (K211448)Pegavision Corporation2021-12-06
ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) (K210930)Johnson & Johnson Vision Care, Inc.2021-11-29
Avaira Vitality (K213164)CooperVision, Inc.2021-10-26
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (K210975)Bausch & Lomb, Incorporated2021-05-24
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens (K210609)Vp Optics2021-04-27
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere (K210436)Alcon Laboratories, Inc.2021-04-12
Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo (K202129)Largan Medical Co., Ltd.2021-04-01
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens (K200618)Visco Vision, Inc.2020-12-07
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (K201268)Plexus Optix, Inc.2020-10-21
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) (K202756)CooperVision, Inc.2020-10-20
Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses (K200296)Pegavision Corporation2020-10-15
Optixon 1-Day (K201013)Optixon, Inc.2020-09-18
Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens (K201080)Visco Vision, Inc.2020-07-15
Miru 1day UpSide (midafilcon A) (K193399)Menicon Co, Ltd.2020-06-17
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism (K200528)Bausch + Lomb, Incorporated2020-06-02
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC (K191763)CooperVision, Inc.2020-03-23
ACUVUE (senofilcon A) Soft Contact Lens Multifocal (K200243)Johnson & Johnson Vision Care, Inc.2020-03-17
Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses (K192225)Vizionfocus, Inc.2019-12-09
OxySoft (olifilcon C) silicone hydrogel soft contact lens (K191397)Visco Vision, Inc.2019-10-02
ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens (K192129)Clearlab SG Pte, Ltd.2019-09-27
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K191929)Unicon Optical Co., Ltd.2019-09-17
Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens (K183670)Visco Vision, Inc.2019-09-13
Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens (K191121)Lentechs, LLC2019-09-06
Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac (K182734)Unicon Optical Co., Ltd.2019-05-16
MyDay (K190965)CooperVision, Inc.2019-04-29
ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) (K181656)Eyemed Technologies S.R.L.2019-03-05
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives (K190045)Alcon Laboratories, Inc.2019-02-06
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric (K182782)Alcon Laboratories, Inc.2019-01-18
Precision1 (K182902)Alcon Laboratories, Inc.2018-12-11
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (K181920)CooperVision, Inc.2018-12-11
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens (K182249)Bausch & Lomb, Incorporated2018-11-30
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal (K181454)Alcon Laboratories, Inc.2018-11-21
Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (K182674)Largan Medical Co., Ltd.2018-11-13
Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K182523)Largan Medical Co., Ltd.2018-11-01
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) (K182247)Vizionfocus, Inc.2018-10-12
Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens (K181349)Visco Vision, Inc.2018-09-19
Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens (K181558)Gelflex Laboratories2018-09-06
FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions (K181796)Alcon Laboratories, Inc.2018-08-03
Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (K181232)Largan Medical Co., Ltd.2018-06-29
Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA (K181230)Largan Medical Co., Ltd.2018-06-25
Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) (K181050)Qualimed Srl2018-06-13
Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses (K180985)Supervision Optimax Sdn Bhd2018-06-08
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens (K180819)Menicon Co, Ltd.2018-05-16
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal (K180669)Alcon Laboratories, Inc.2018-04-27
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens (K180322)Visco Vision, Inc.2018-04-20
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal (K180398)Alcon Laboratories, Inc.2018-04-10
ACUVUE OASYS (senofilcon A) with Photochromic Additive (K180299)Johnson & Johnson Vision Care, Inc.2018-04-10
OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens (K173958)Visco Vision, Inc.2018-04-03
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens (K180004)Menicon Co, Ltd.2018-02-22
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Every clearance here is in the API, with alerts when new ones post.