Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LPL — Predicate Candidate Screening

486 FDA 510(k) clearances under this product code; the 50 most recent screened below.

85 daysmedian FDA review time
251 days90th percentile
486clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone HydrogINTEROJO, Inc.2026-05-291010
K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) CPegavision Corporation2026-05-212330
K261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic)Pegavision Corporation2026-05-19290
K253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILGEO MEDICAL CO., LTD.2026-04-291460
K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft St. shine Optical Co., Ltd.2026-03-19790
K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic)Pegavision Corporation2026-03-132250
K254052DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalAlcon Laboratories, Inc.2026-02-13580
K251683Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) ConBruno Vision Care, LLC2025-12-232070
K250364Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft St. shine Optical Co., Ltd.2025-10-072390
K244009Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilYung Sheng Optical Co., Ltd.2025-09-252730
K251095Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LenPegavision Corporation2025-09-171600
K251573VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilVizionfocus, Inc.2025-09-101110
K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted,E.O.S Co., Ltd.2025-07-303130
K243868Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic)Pegavision Corporation2025-07-021970
K242056miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE ColorBenq Materials Corporation2025-04-172760
K243953Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact LVizionfocus, Inc.2025-04-101080
K241884HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact LensHunan Haipuming Technology Co., Ltd.2025-03-202650
K242916Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) CLargan Medical Co., Ltd.2025-02-041330
K243909Precision1; Precision1 for Astigmatism; Dailies Total1; DailAlcon Laboratories, Inc.2025-01-13250
K242413VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilVizionfocus, Inc.2024-12-171250
K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV AsYung Sheng Optical Co., Ltd.2024-12-164590
K240918Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) ConBruno Vision Care, LLC2024-10-252050
K242391Lucens 41 (senofilcon C) Silicone Hydrogel Soft (HydrophilicLucens Technology Co., Ltd.2024-10-08570
K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) ConX-Cel Specialty Contacts, A Walman Optical Company2024-08-14300
K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENUnicon Optical Co., Ltd.2024-07-12290
K240477Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (HydroSt. shine Optical Co., Ltd.2024-07-011320
K232649Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LenPegavision Corporation2024-05-082510
K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Innova Vision, Inc.2024-04-17540
K233221Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (Metro Optics of Austin, Inc.2024-02-061310
K234127Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), CooperVision, Inc.2024-01-25280
K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact LHoya Lamphun , Ltd.2024-01-034210
K233856Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 forAlcon Laboratories, Inc.2023-12-29241
K223585Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilYung Sheng Optical Co., Ltd.2023-12-203840
K230954Samfilcon B Custom Contact LensBausch + Lomb, Incorporated2023-11-172270
K232921DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® MultAlcon Laboratories, Inc.2023-11-16581
K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (HydrophiInnova Vision, Inc.2023-11-161210
K230824IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact LensArt Optical Contact Lens, Inc.2023-09-061660
K222885Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) ContacPegavision Corporation2023-05-312500
K230785Precision1, Precision1 for AstigmatismAlcon Laboratories, Inc.2023-04-20290
K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) ContInnova Vision, Inc.2023-03-131670
K220613Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact LensBausch & Lomb, Incorporated2023-03-083700
K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUEINTEROJO, Inc.2022-10-041320
K222500AIR OPTIX COLORSAlcon Laboratories, Inc.2022-09-15280
K220143BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LenShenzhen Dashicheng Optical Technology Co., Ltd.2022-09-082330
K213983Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) CYung Sheng Optical Co., Ltd.2022-09-022560
K220045TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (TinteDk Medivision Co., Ltd.2022-08-052120
K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) CoInnova Vision, Inc.2022-05-132280
K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable ConCooperVision, Inc.2022-02-04254
K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) CoPegavision Corporation2022-02-022540
K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Unicon Optical Co., Ltd.2022-01-181110

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda