Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 28
- Latest Decision
- 2026-09-18
Clearances · page 1 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K262637 | SLIT LAMP SL-D4 (Type: LED) | Topcon Corporation | HJO | Class II | 2026-09-18 |
| K262495 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | LPL | Class II | 2026-09-17 |
| K261255 | KOWA FM-600 | Kowa Company, Ltd. Chofu Factory | MYC | Class II | 2026-09-11 |
| K261019 | ANTERION | Heidelberg Engineering GmbH | OBO | Class II | 2026-09-11 |
| K262479 | TearCare System | Sight Sciences, Inc. | ORZ | Class II | 2026-08-18 |
| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. | LPN | Class II | 2026-08-13 |
| K261312 | Temporary Keratoprosthesis (QuickSet TKP) | Eyekon Medical, Inc. | MLP | Class II | 2026-07-24 |
| K261812 | 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 | HOYA Lamphun , Ltd. | MVN | Class II | 2026-07-07 |
| K253704 | iPredict-DR | iHealthscreen, Inc. | PIB | Class II | 2026-07-02 |
| K253176 | TearView | Beyond 700 Pty, Ltd. | HKI | Class II | 2026-06-22 |
| K261174 | RxSight® Insertion Device | Rxsight, Inc. | MSS | Class I | 2026-06-10 |
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus | INTEROJO, Inc. | LPL | Class II | 2026-05-29 |
| K253352 | 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 | Pegavision Corporation | LPL | Class II | 2026-05-21 |
| K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | 2026-05-19 |
| K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+ | Bausch and Lomb | HQC | Class II | 2026-05-15 |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | OBO | Class II | 2026-05-07 |
| K252455 | FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. | QQJ | Class II | 2026-04-30 |
| K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES | GEO MEDICAL CO., LTD. | LPL | Class II | 2026-04-29 |
| K252409 | TearCare MGX System | Sight Sciences, Inc. | ORZ | Class II | 2026-04-27 |
| K252979 | Voyager DSLT (430840610) | Belkin Vision, Ltd. | HQF | Class II | 2026-04-07 |
| K253586 | RM Electrode (RMH 25-01) | Retmap, Inc. | HLZ | Class II | 2026-04-01 |
| K253822 | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd. | HQD | Class II | 2026-03-27 |
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | HQC | Class II | 2026-03-25 |
| K254269 | 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 | St. shine Optical Co., Ltd. | LPL | Class II | 2026-03-19 |
| K253834 | VISUREF 600 | Carl Zeiss Vision GmbH | HJO | Class II | 2026-03-18 |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | 2026-03-13 |
| K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | MXK | Class II | 2026-03-13 |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories, Inc. | LPL | Class II | 2026-02-13 |
| K252175 | LANDR Contact LENS Case | Fourth Axis, LLC | LRX | Class II | 2026-02-10 |
| K251507 | INTEGRE LIO | Quantel Medical | HQF | Class II | 2026-02-06 |
| K251353 | Eyer 2 | Phelcom Technologies | HKI | Class II | 2026-01-16 |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | OBO | Class II | 2025-12-23 |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) | Bruno Vision Care, LLC | LPL | Class II | 2025-12-23 |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | MXK | Class II | 2025-12-18 |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | HKI | Class II | 2025-12-12 |
| K250501 | System Sophi | This AG | HQC | Class II | 2025-11-14 |
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | HKX | Class II | 2025-11-07 |
| K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | HQF | Class II | 2025-10-29 |
| K251876 | cleadew GP hydra one | Ophtecs Corporation | MRC | Class II | 2025-10-09 |
| K250364 | 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 | St. shine Optical Co., Ltd. | LPL | Class II | 2025-10-07 |
| DEN250016 | Essilor® Stellest® | Essilor Of America, Inc. | QUR | Class II | 2025-09-25 |
| K244009 | 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) | Yung Sheng Optical Co., Ltd. | LPL | Class II | 2025-09-25 |
| K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | OOE | Class II | 2025-09-24 |
| K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | LPL | Class II | 2025-09-17 |
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | MSS | Class I | 2025-09-16 |
| K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus, Inc. | LPL | Class II | 2025-09-10 |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | HKI | Class II | 2025-09-04 |
| K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | HKI | Class II | 2025-08-14 |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | HQC | Class II | 2025-08-08 |
| K250495 | MINI VP1 (PL67_F); MINI VP1 (PL61_F) | Avizor S.A. | LRX | Class II | 2025-08-01 |
| K242855 | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | E.O.S Co., Ltd. | LPL | Class II | 2025-07-30 |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | OBO | Class II | 2025-07-18 |
| K243868 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | 2025-07-02 |
| K250143 | Digital Prism Correction Feature (DPCF) | Apple, Inc. | SCW | Class I | 2025-06-23 |
| K243014 | EyeQ nanoECP | Eyeq, Inc. | HQF | Class II | 2025-06-18 |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | Carl Zeiss Meditec Cataract Technology, Inc. | HQC | Class II | 2025-06-11 |
| K250868 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | OBO | Class II | 2025-05-12 |
| K250683 | Resolve Fundus Camera | Optain Health, Inc. | HKI | Class II | 2025-04-30 |
| K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | OOE | Class II | 2025-04-28 |
| K241931 | OcuMet Beacon (OCUB100) | Ocusciences, Inc. | MYC | Class II | 2025-04-22 |
| K243878 | CLARUS (700) | Carl Zeiss Meditec, Inc. | QER | Class II | 2025-04-17 |
| K242056 | miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus | Benq Materials Corporation | LPL | Class II | 2025-04-17 |
| K242786 | TearCare MGX System | Sight Sciences, Inc. | ORZ | Class II | 2025-04-15 |
| K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Vizionfocus, Inc. | LPL | Class II | 2025-04-10 |
| K243819 | Luminopia | Luminopia, Inc. | QQU | Class II | 2025-04-09 |
| K240615 | Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. | HQF | Class II | 2025-04-03 |
| K241884 | HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) | Hunan Haipuming Technology Co., Ltd. | LPL | Class II | 2025-03-20 |
| K243504 | MAIA (AHMACME001) | Centervue S.P.A. | MYC | Class II | 2025-03-17 |
| K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | LPL | Class II | 2025-02-04 |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric | Alcon Laboratories, Inc. | LPL | Class II | 2025-01-13 |
| K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens | Vizionfocus, Inc. | LPL | Class II | 2024-12-17 |
| K243664 | Sentinel Camera | Ai Optics | HKI | Class II | 2024-12-17 |
| K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear | Yung Sheng Optical Co., Ltd. | LPL | Class II | 2024-12-16 |
| K240924 | Anterion | Heidelberg Engineering GmbH | OBO | Class II | 2024-12-13 |
| K241389 | Infrascanner Model 2500 (Model 2500) | Infrascan, Inc. | OPT | Class II | 2024-12-12 |
| K242508 | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | HKI | Class II | 2024-12-09 |
| K240512 | Tixel i (TXLI0001) | Novoxel , Ltd. | ORZ | Class II | 2024-11-04 |
| DEN230083 | Valeda Light Delivery System | Lumithera, Inc. | SDE | Class II | 2024-11-04 |
| K242393 | Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses | Acuity Polymers, Inc. | HQD | Class II | 2024-11-01 |
| K242397 | LYNX Photocoagulator | Norlase Aps | HQF | Class II | 2024-10-25 |
| K240918 | 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 | Bruno Vision Care, LLC | LPL | Class II | 2024-10-25 |
| K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | Tianjin Mastervision Technology Co., Ltd. | HQD | Class II | 2024-10-22 |
| K242058 | Digital Prism Correction Feature (DPCF) | Apple, Inc. | SCW | Class I | 2024-10-21 |
| K241163 | SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | OBO | Class II | 2024-10-11 |
| K242389 | EyeGility Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated | MSS | Class I | 2024-10-10 |
| K240095 | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) | Shanghai Care US Medical Product Co., Ltd. | LRX | Class II | 2024-10-09 |
| K242391 | Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Lucens Technology Co., Ltd. | LPL | Class II | 2024-10-08 |
| K241447 | iCare ST500 (TA04) | Icare Finland OY | HKY | Class II | 2024-09-27 |
| K233911 | VISULAS combi | Carl Zeiss Meditec, AG | HQF | Class II | 2024-09-06 |
| K223700 | BOSS | Intelon Optics, Inc. | MXK | Class II | 2024-08-16 |
| K241571 | BostonSight® Specialty Lenses | Boston Foundation For Sight, Inc. D/B/A Bostonsight | HQD | Class II | 2024-08-14 |
| K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) | X-Cel Specialty Contacts, A Walman Optical Company | LPL | Class II | 2024-08-14 |
| K233720 | Luminopia | Luminopia, Inc. | QQU | Class II | 2024-08-08 |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch and Lomb, Incorporated | HQC | Class II | 2024-07-26 |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Topcon Corporation | OBO | Class II | 2024-07-17 |
| K241707 | OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL | Unicon Optical Co., Ltd. | LPL | Class II | 2024-07-12 |
| K240221 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | OBO | Class II | 2024-07-01 |
| K240477 | 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 | St. shine Optical Co., Ltd. | LPL | Class II | 2024-07-01 |
| DEN230055 | FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System | Balance Ophthalmics, Inc. | QQJ | Class II | 2024-06-27 |
| K233398 | Faros Surgical System | Oertli Instrumente AG | HQC | Class II | 2024-06-27 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.