| P200TE (A10700) (K233602) | Optos Plc. | 2024-05-09 |
| Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (K232649) | Pegavision Corporation | 2024-05-08 |
| Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) (K233516) | Reichert, Inc. | 2024-05-01 |
| AEYE-DS (K240058) | Aeye Health, Inc. | 2024-04-23 |
| Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens (K240519) | Innova Vision, Inc. | 2024-04-17 |
| 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (K233561) | Topcon Corporation | 2024-04-10 |
| Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens (K240618) | Acuity Polymers, Inc. | 2024-04-03 |
| HP-OCT (HP-OCT) (K231760) | Cylite Pty. , Ltd. | 2024-03-08 |
| RESCAN 700 (K233421) | Carl Zeiss Meditec, AG | 2024-03-08 |
| Stellaris Elite vision enhancement system (K232084) | Bausch and Lomb | 2024-02-26 |
| Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) (K233325) | Visionary Optics, LLC | 2024-02-21 |
| CATS-L Tonometer™ Prism (K234037) | Cats Tonometer, LLC | 2024-02-09 |
| Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (K233221) | Metro Optics of Austin, Inc. | 2024-02-06 |
| MR Q; MR Q SUPINE; MR Q SLT (K232417) | Meridian AG | 2024-01-25 |
| Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker (K234127) | CooperVision, Inc. | 2024-01-25 |
| Centurion™ Vision System (Active Sentry™) (8065753057) (K233902) | Alcon Laboratories, Inc. | 2024-01-10 |
| 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 |
| TearCare MGX System (K231084) | Sight Sciences, Inc. | 2023-12-27 |
| Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (K223585) | Yung Sheng Optical Co., Ltd. | 2023-12-20 |
| Eagle device (K230722) | Belkin Vision, Ltd. | 2023-12-08 |
| RM Electrode (RMH 23-01) (K232273) | Retmap, Inc. | 2023-12-07 |
| Optina-4C (MHRC-C1N) (K231230) | Optina Diagnostics, Inc. | 2023-12-05 |
| Zilia Ocular FC (ZIL-10002) (K230627) | Zilia, Inc. | 2023-11-20 |
| Samfilcon B Custom Contact Lens (K230954) | Bausch + Lomb, Incorporated | 2023-11-17 |
| 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 |
| VS Tabletop Tonometer (K223739) | Medimaging Integrated Solution, Inc. | 2023-11-08 |
| 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (K231222) | Topcon Corporation | 2023-10-30 |
| VISULAS green (K232051) | Carl Zeiss Meditec | 2023-10-24 |
| Applanation Tonometer HT-5000 (K232143) | Huvitz Co., Ltd. | 2023-10-23 |
| SPECTRALIS HRA+OCT and variants (K223557) | Heidelberg Engineering GmbH | 2023-10-20 |
| Anterion (K230897) | Heidelberg Engineering GmbH | 2023-10-11 |
| VISULAS yag (K230350) | Carl Zeiss Meditec, Inc. | 2023-09-22 |
| Accuject Refra Injector AR2900 (K231106) | Medicel AG | 2023-09-19 |
| Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse (K231011) | Meridian AG | 2023-09-12 |
| Phoenix ICON, Phoenix ICON GO (K223575) | Neolight, LLC | 2023-09-06 |
| IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (K230824) | Art Optical Contact Lens, Inc. | 2023-09-06 |
| MS-39 (K221601) | C.S.O. S.R.L. | 2023-09-01 |
| Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) (K231123) | Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. | 2023-08-30 |
| P200TE (A10700) (K231673) | Optos Plc. | 2023-08-18 |
| RxSight® Insertion Device (63002) (K231838) | Rxsight, Inc. | 2023-08-15 |
| QUATERA 700 (K230858) | Carl Zeiss Meditec, AG | 2023-07-31 |
| MYAH (K222933) | Visia Imaging S.R.L. | 2023-06-29 |
| EyeArt v2.2.0 (K223357) | Eyenuk, Inc. | 2023-06-16 |
| NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens (K230910) | Acculens, Inc. | 2023-06-16 |
| Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens (K230965) | Acuity Polymers, Inc. | 2023-06-16 |
| RxSight Insertion Device (K231466) | Rxsight, Inc. | 2023-06-12 |
| CorNeat EverPatch (K223074) | Corneat Vision , Ltd. | 2023-06-02 |
| Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (K222885) | Pegavision Corporation | 2023-05-31 |
| Ahmed® Glaucoma Valve Model FP7 (K230975) | New World Medical, Inc. | 2023-05-12 |
| Ahmed® Glaucoma Valve Model FP8 (K231051) | New World Medical, Inc. | 2023-05-12 |
| Retitrack (K222484) | C. Light Technologies, Inc. | 2023-05-09 |
| Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses (K221768) | Paragon Vision Sciences, Inc. | 2023-05-05 |
| Precision1, Precision1 for Astigmatism (K230785) | Alcon Laboratories, Inc. | 2023-04-20 |
| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
| CIRRUS HD-OCT (K222200) | Carl Zeiss Meditec, Inc. | 2023-04-13 |
| Catalys™ Precision Laser System (K223838) | Amo Manufacturing USA, LLC | 2023-04-12 |
| ZeptoLink IOL Positioning System (K223763) | Centricity Vision, Inc. | 2023-04-11 |
| Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX (K221320) | Nidek Co., Ltd. | 2023-03-30 |
| iExaminer System with Panoptic Plus (K223381) | Welch Allyn, Inc. | 2023-03-15 |
| 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, Incorporated | 2023-03-08 |
| Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) (K230228) | Iridex Corporation | 2023-02-23 |
| Eyer Retinal Camera NM-STD (K221329) | Phelcom Technologies | 2023-02-22 |
| R:GEN (K220974) | Lutronic Vision, Inc. | 2022-12-27 |
| Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) (K223394) | Visionary Optics, LLC | 2022-12-07 |
| Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (K222541) | Bausch & Lomb, Incorporated | 2022-12-06 |
| Kowa SL-19 (K222372) | Kowa Company , Ltd. | 2022-11-21 |
| AEYE-DS (K221183) | Aeye Health, Inc. | 2022-11-10 |
| SOLIX (K222166) | Optovue, Inc. | 2022-11-09 |
| Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) (K223132) | Iridex Corporation | 2022-11-09 |
| Luminopia One (K221659) | Luminopia, Inc. | 2022-11-04 |
| Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers (K220263) | Vortex Surgical, Inc. | 2022-11-03 |
| Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo (K222395) | Ellex Medical Pty, Ltd. | 2022-11-02 |
| Aqua Naina Plus Sterile Saline Solution (K221263) | Chemtex USA, Inc. | 2022-10-12 |
| ECHO Photocoagulator (K222157) | Norlase | 2022-10-11 |
| iCare IC200 (K220852) | Icare Finland OY | 2022-10-06 |
| POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens (K221517) | INTEROJO, Inc. | 2022-10-04 |
| CureSight-CS100 (K221375) | Novasight , Ltd. | 2022-09-29 |
| AIR OPTIX COLORS (K222500) | Alcon Laboratories, Inc. | 2022-09-15 |
| MICOR Lens Fragmentation System (K214028) | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-09-09 |
| BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens (K220143) | Shenzhen Dashicheng Optical Technology Co., Ltd. | 2022-09-08 |
| EyeCTester (K203594) | Neuro-Eye Diagnostic Systems, LLC | 2022-09-07 |
| Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear (K213983) | Yung Sheng Optical Co., Ltd. | 2022-09-02 |
| Non-Mydriatic Retinal Camera NW500 (K221111) | Topcon Corporation | 2022-08-29 |
| miCOR System Lens Fragmentation System (K222236) | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-08-24 |
| Visibly Digital Acuity Product (K220090) | Visibly, Inc. | 2022-08-12 |
| UniVit HE, UniVit UHS (K212763) | Visioncare Devices, LLC | 2022-08-10 |
| TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (K220045) | Dk Medivision Co., Ltd. | 2022-08-05 |
| iStent infinite Trabecular Micro-Bypass System, Model iS3 (K220032) | Glaukos Corporation | 2022-08-02 |
| Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems (K220877) | Lumenis Be, Inc. | 2022-07-15 |
| EZYPOR (K212741) | Fci (France Chirurgie Instrumentation) Sas | 2022-06-24 |
| ZEPTO Precision Capsulotomy System (K221188) | Centricity Vision, Inc. | 2022-06-23 |
| IDx-DR v2.3 (K213037) | Digital Diagnostics, Inc. | 2022-06-17 |
| EVA NEXUS Ophthalmic Surgical System (K213467) | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022-06-14 |
| ALLY Adaptive Cataract Treatment System (K220259) | Lensar, Inc. | 2022-06-09 |
| CATALYS Precision Laser system (K220516) | Amo Manufacturing USA, LLC | 2022-05-17 |
| Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K213119) | Innova Vision, Inc. | 2022-05-13 |
| Capsulo (K220430) | Quantel Medical | 2022-05-12 |