| Temporary Keratoprosthesis (QuickSet TKP™) (K261312) | Eyekon Medical, Inc. | 2026-07-24 |
| 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 (K261812) | HOYA Lamphun , Ltd. | 2026-07-07 |
| iPredict-DR (K253704) | iHealthscreen, Inc. | 2026-07-02 |
| TearView (K253176) | Beyond 700 Pty, Ltd. | 2026-06-22 |
| RxSight® Insertion Device (K261174) | Rxsight, Inc. | 2026-06-10 |
| 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 Corporation | 2026-05-21 |
| Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K261299) | Pegavision Corporation | 2026-05-19 |
| 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™+ (K261264) | Bausch and Lomb | 2026-05-15 |
| SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module (K253837) | Heidelberg Engineering GmbH | 2026-05-07 |
| FSYX Ocular Pressure Adjusting Pump (K252455) | Balance Ophthalmics, Inc. | 2026-04-30 |
| 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 |
| TearCare MGX System (K252409) | Sight Sciences, Inc. | 2026-04-27 |
| Voyager DSLT (430840610) (K252979) | Belkin Vision, Ltd. | 2026-04-07 |
| RM Electrode (RMH 25-01) (K253586) | Retmap, Inc. | 2026-04-01 |
| GPA (hexafocon A) Rigid Gas Permeable Contact Lenses (K253822) | Zhuhai Fitlens Medical Technology Co., Ltd. | 2026-03-27 |
| Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (K252052) | Bausch and Lomb, Incorporated | 2026-03-25 |
| 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 |
| VISUREF 600 (K253834) | Carl Zeiss Vision GmbH | 2026-03-18 |
| Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K252385) | Pegavision Corporation | 2026-03-13 |
| Pentacam® Cornea OCT (K251848) | Oculus Optikgeräte GmbH | 2026-03-13 |
| DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (K254052) | Alcon Laboratories, Inc. | 2026-02-13 |
| LANDR Contact LENS Case (K252175) | Fourth Axis, LLC | 2026-02-10 |
| INTEGRE LIO (K251507) | Quantel Medical | 2026-02-06 |
| Eyer 2 (K251353) | Phelcom Technologies | 2026-01-16 |
| UNITY DX (UDX) (K252633) | Cylite Pty. , Ltd. | 2025-12-23 |
| Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) (K251683) | Bruno Vision Care, LLC | 2025-12-23 |
| Tomey Optical Biometer OA-2000 (OA-2000) (K252348) | Tomey Corporation | 2025-12-18 |
| Fundus On Phone Non Mydriatic (FOP NM-10) (K252120) | Remidio Innovative Solutions Private Limited | 2025-12-12 |
| System Sophi (K250501) | This AG | 2025-11-14 |
| AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (K253039) | Topcon Corporation | 2025-11-07 |
| Navilas Laser System 577sl (156691) (K251772) | Od-Os GmbH | 2025-10-29 |
| cleadew GP hydra one (K251876) | Ophtecs Corporation | 2025-10-09 |
| 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 |
| Essilor® Stellest® (DEN250016) | Essilor Of America, Inc. | 2025-09-25 |
| 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 |
| LenSx Laser System (8065000944) (K252682) | Alcon Laboratories, Inc. | 2025-09-24 |
| Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (K251095) | Pegavision Corporation | 2025-09-17 |
| ACCUJECT Injector Set 2.1-1P (LP604590) (K252540) | Medicel AG | 2025-09-16 |
| VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (K251573) | Vizionfocus, Inc. | 2025-09-10 |
| Optina-4C (MHRC-C1N) (K250770) | Optina Diagnostics, Inc. | 2025-09-04 |
| 3nethra neo HD FA; 3nethra neo HD (K243600) | Forus Health Pvt.Ltd | 2025-08-14 |
| MICOR 700 with Auto I/A (K243395) | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-08-08 |
| MINI VP1 (PL67_F); MINI VP1 (PL61_F) (K250495) | Avizor S.A. | 2025-08-01 |
| P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (K242855) | E.O.S Co., Ltd. | 2025-07-30 |
| Tomey Cornea/Anterior Segment OCT (CASIA2) (K250553) | Tomey Corporation | 2025-07-18 |
| Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K243868) | Pegavision Corporation | 2025-07-02 |
| Digital Prism Correction Feature (DPCF) (K250143) | Apple, Inc. | 2025-06-23 |
| EyeQ nanoECP (K243014) | Eyeq, Inc. | 2025-06-18 |
| MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) (K242801) | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-06-11 |
| SPECTRALIS HRA+OCT and variants (K250868) | Heidelberg Engineering GmbH | 2025-05-12 |
| Resolve Fundus Camera (K250683) | Optain Health, Inc. | 2025-04-30 |
| LenSx Laser System (8065998162) (K243896) | Alcon Laboratories, Inc. | 2025-04-28 |
| OcuMet Beacon (OCUB100) (K241931) | Ocusciences, Inc. | 2025-04-22 |
| miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus (K242056) | Benq Materials Corporation | 2025-04-17 |
| CLARUS (700) (K243878) | Carl Zeiss Meditec, Inc. | 2025-04-17 |
| TearCare MGX System (K242786) | Sight Sciences, Inc. | 2025-04-15 |
| Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (K243953) | Vizionfocus, Inc. | 2025-04-10 |
| Luminopia (K243819) | Luminopia, Inc. | 2025-04-09 |
| Leos Laser and Endoscopy System (K240615) | Beaver-Visitec International, Inc. | 2025-04-03 |
| HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) (K241884) | Hunan Haipuming Technology Co., Ltd. | 2025-03-20 |
| MAIA (AHMACME001) (K243504) | Centervue S.P.A. | 2025-03-17 |
| 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 |
| Sentinel Camera (K243664) | Ai Optics | 2024-12-17 |
| 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 |
| Anterion (K240924) | Heidelberg Engineering GmbH | 2024-12-13 |
| Infrascanner Model 2500 (Model 2500) (K241389) | Infrascan, Inc. | 2024-12-12 |
| Verily Numetric Retinal Camera (K242508) | Verily Life Sciences, LLC | 2024-12-09 |
| Tixel i (TXLI0001) (K240512) | Novoxel , Ltd. | 2024-11-04 |
| Valeda Light Delivery System (DEN230083) | Lumithera, Inc. | 2024-11-04 |
| Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses (K242393) | Acuity Polymers, Inc. | 2024-11-01 |
| LYNX Photocoagulator (K242397) | Norlase Aps | 2024-10-25 |
| 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, LLC | 2024-10-25 |
| SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (K241398) | Tianjin Mastervision Technology Co., Ltd. | 2024-10-22 |
| Digital Prism Correction Feature (DPCF) (K242058) | Apple, Inc. | 2024-10-21 |
| SPECTRALIS with Flex Module (K241163) | Heidelberg Engineering GmbH | 2024-10-11 |
| EyeGility™ Inserter for Preloaded enVista IOLs (K242389) | Bausch & Lomb, Incorporated | 2024-10-10 |
| CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (K240095) | Shanghai Care US Medical Product Co., Ltd. | 2024-10-09 |
| Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens (K242391) | Lucens Technology Co., Ltd. | 2024-10-08 |
| iCare ST500 (TA04) (K241447) | Icare Finland OY | 2024-09-27 |
| VISULAS combi (K233911) | Carl Zeiss Meditec, AG | 2024-09-06 |
| BOSS™ (K223700) | Intelon Optics, Inc. | 2024-08-16 |
| Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) (K242059) | X-Cel Specialty Contacts, A Walman Optical Company | 2024-08-14 |
| BostonSight® Specialty Lenses (K241571) | Boston Foundation For Sight, Inc. D/B/A Bostonsight | 2024-08-14 |
| Luminopia (K233720) | Luminopia, Inc. | 2024-08-08 |
| Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (K240169) | Bausch and Lomb, Incorporated | 2024-07-26 |
| 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System (K241081) | Topcon Corporation | 2024-07-17 |
| 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 |
| SPECTRALIS HRA+OCT and variants (K240221) | Heidelberg Engineering GmbH | 2024-07-01 |
| FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System (DEN230055) | Balance Ophthalmics, Inc. | 2024-06-27 |
| Faros Surgical System (K233398) | Oertli Instrumente AG | 2024-06-27 |
| UNITY VCS (8065000296); UNITY CS (8065000297) (K233876) | Alcon Laboratories, Inc. | 2024-06-21 |
| VERVE (K232930) | Oculomotor Technologies | 2024-06-13 |
| LFR-260 (K233295) | Evolution Optiks Limited | 2024-05-31 |
| CIRRUS™ HD-OCT Model 6000 (K233933) | Carl Zeiss Meditec, Inc. | 2024-05-17 |
| Notal Vision Home Optical Coherence Tomography (OCT) System (DEN230043) | Notal Vision, Inc. | 2024-05-15 |
| CANON Fundus Camera CR-10 (CR-10) (K241049) | Canon, Inc. | 2024-05-15 |