| Vista Ophthalmics Vitrectomy Probe (K220030) | Vista Ophthalmics, LLC | 2022-05-04 |
| Kerasave (DEN200063) | Al.Chi.Mi.A. S.R.L | 2022-05-02 |
| Tomey Cornea/Anterior Segment OCT CASIA2 (K213265) | Tomey Corporation | 2022-04-27 |
| FEMTO LDV Z8 Femtosecond Surgical Laser (K213559) | Sie Ag,Surgical Instrument Engineering | 2022-04-21 |
| QUATERA 700 (K212241) | Carl Zeiss Meditec, AG | 2022-04-19 |
| Iridex 810 Laser (K213592) | Iridex Corporation | 2022-03-23 |
| Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (K212631) | Contamac, Ltd. | 2022-03-17 |
| iTEAR100 Neurostimulator (K213623) | Olympic Ophthalmics | 2022-03-16 |
| MYAH (K211868) | Visia Imaging S.R.L. | 2022-03-01 |
| Infrascanner (K211617) | Infrascan, Inc. | 2022-02-09 |
| MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (K220070) | CooperVision, Inc. | 2022-02-04 |
| EndoSerter-PL (K203586) | Corneagen, Inc. | 2022-02-02 |
| Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses (K211603) | Pegavision Corporation | 2022-02-02 |
| iCare HOME2 (K211355) | Icare Finland OY | 2022-01-25 |
| Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens (K213216) | Unicon Optical Co., Ltd. | 2022-01-18 |
| 3N Contact Lenses Adjunct Cleaner (K211361) | Suzhou 3N Biological Technology Co., Ltd. | 2022-01-13 |
| Custom Stable Rigid Gas Permeable Scleral Contact Lens (K213880) | Valley Contax, Inc. | 2022-01-07 |
| Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K213538) | Acuity Polymers, Inc. | 2021-12-30 |
| Alcon (serafilcon A) soft contact lenses for daily wear (K212806) | Alcon Laboratories, Inc. | 2021-12-28 |
| DRSplus (K213705) | Centervue S.P.A. | 2021-12-21 |
| TearCare System (K213045) | Sight Sciences, Inc. | 2021-12-21 |
| Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo (K212630) | Ellex Medical Pty, Ltd. | 2021-12-16 |
| ZEPTO Precision Capsulotomy System (K210827) | Centricity Vision, Inc. | 2021-12-14 |
| Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses (K211448) | Pegavision Corporation | 2021-12-06 |
| ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) (K210930) | Johnson & Johnson Vision Care, Inc. | 2021-11-29 |
| Anterion (K211817) | Heidelberg Engineering GmbH | 2021-11-05 |
| Avaira Vitality (K213164) | CooperVision, Inc. | 2021-10-26 |
| Luminopia One (DEN210005) | Luminopia, Inc. | 2021-10-20 |
| CLAREON MONARCH IV IOL Delivery System (K212039) | Alcon Laboratories, Inc. | 2021-08-23 |
| EIDON FA, EIDON, EIDON AF, EIDON UWFL (K211328) | Centervue S.P.A. | 2021-08-19 |
| Myopia Master (K202989) | Oculus Optikgeräte GmbH | 2021-07-14 |
| CATS®-D Tonometer Prism (K203850) | Cats Tonometer, LLC | 2021-06-14 |
| Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants (K203569) | Fci (France Chirurgie Instrumentation) Sas | 2021-06-11 |
| IDx-DR (K203629) | Digital Diagnostics, Inc. | 2021-06-10 |
| ABT12 multi-purpose solution (K202932) | Bausch & Lomb, Incorporated | 2021-05-28 |
| OTE MPS 045 Multi-purpose Lens Care Solution (K210051) | Ote North America, LLC | 2021-05-26 |
| Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (K210975) | Bausch & Lomb, Incorporated | 2021-05-24 |
| Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) (K202860) | Valley Contax, Inc. | 2021-05-11 |
| AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens (K210609) | Vp Optics | 2021-04-27 |
| NFC-600 Automated Portable Retinal Camera (K210197) | Crystalvue Medical Corporation | 2021-04-13 |
| RetCam Envision (K203500) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2021-04-13 |
| Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere (K210436) | Alcon Laboratories, Inc. | 2021-04-12 |
| Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K203571) | Acuity Polymers, Inc. | 2021-04-09 |
| CATALYS Precision Laser System (K210701) | Amo Manufacturing USA, LLC | 2021-04-07 |
| VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System (K210300) | Vuesonic, LLC | 2021-04-01 |
| 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 |
| VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (K203060) | Johnson & Johnson Surgical Vision, Inc. | 2021-03-12 |
| Lumenis Stellar M22 (DEN200028) | Lumenis, Ltd. | 2021-02-23 |
| Fundus Camera (K202097) | Huvitz Co., Ltd. | 2021-02-02 |
| VX650 (K202221) | Luneau Technology Operations | 2021-01-29 |
| CryoTreQ (K202038) | VitreQ BV | 2020-12-30 |
| Ophthalmic Yag Laser System YC-200 (K203130) | Nidek Co., Ltd. | 2020-12-07 |
| HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens (K200618) | Visco Vision, Inc. | 2020-12-07 |
| Optomed Smartscope M5 with Optomed Smartscope FA (K201325) | Optomed Oyj | 2020-11-20 |
| Iridex 810 Laser (K202760) | Iridex Corporation | 2020-10-21 |
| Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (K201268) | Plexus Optix, Inc. | 2020-10-21 |
| Pentacam AXL Wave (K201724) | Oculus Optikgerate GmbH | 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 |
| xPORT S Lens Fragmentation System (K200207) | Carl Zeiss Meditec Cataract Technology, Inc. | 2020-10-15 |
| Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses (K200296) | Pegavision Corporation | 2020-10-15 |
| Tangible Boost (DEN200002) | Tangible Science, Inc. | 2020-09-24 |
| Boston One Step Liquid Enzymatic Cleaner (K200416) | Bausch & Lomb, Incorporated | 2020-09-23 |
| DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202448) | Alcon Laboratories, Inc. | 2020-09-22 |
| Optixon 1-Day (K201013) | Optixon, Inc. | 2020-09-18 |
| RxSight Contact Lens (K201909) | Rxsight, Inc. | 2020-09-10 |
| Spectralis HRA+OCT and variants (K201252) | Heidelberg Engineering GmbH | 2020-09-09 |
| Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K201194) | Acuity Polymers, Inc. | 2020-09-08 |
| OCT-Camera ID 21101A3 (K200516) | Optomedical Technologies GmbH | 2020-09-02 |
| VICTUS Femtosecond Laser Platform (K200724) | Technolas Perfect Vision GmbH | 2020-09-01 |
| TrueTear Intranasal Tear Neurostimulator (K193589) | Allergan | 2020-08-31 |
| Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202036) | Alcon Laboratories, Inc. | 2020-08-21 |
| LION Photocoagulator (K201623) | Norlase Aps | 2020-08-11 |
| Vitra 810 (K201502) | Quantel Medical | 2020-08-06 |
| EyeArt (K200667) | Eyenuk, Inc. | 2020-08-03 |
| xPORT 304 (miCOR) System Lens Fragmentation System (K200584) | Carl Zeiss Meditec Cataract Technology, Inc. | 2020-07-31 |
| VibrantVue Scleral Saline (K201069) | Dry Eye Innovations, LLC | 2020-07-31 |
| Canon non-mydriatic retinal camera CR series (K201122) | Canon, Inc. | 2020-07-23 |
| 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 |
| Infrascanner (K200203) | Infrascan, Inc. | 2020-07-10 |
| Miru 1day UpSide (midafilcon A) (K193399) | Menicon Co, Ltd. | 2020-06-17 |
| Visalis V500, Visalis S500 (K193376) | Carl Zeiss Meditec, AG | 2020-06-15 |
| bioli lOL Delivery System (K200057) | Ast Products, Inc. | 2020-06-04 |
| MIRA Adapter (K200911) | Phakos | 2020-06-02 |
| Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism (K200528) | Bausch + Lomb, Incorporated | 2020-06-02 |
| XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System (K193319) | Vasoptic Medical, Inc. | 2020-06-01 |
| Phacoemulsification Needle (Tip) and Irrigation Sleeve (K192418) | Raico, LLC | 2020-05-27 |
| Aqua Naina Sterile Saline Solution (K193441) | Chemtex USA, Inc. | 2020-05-26 |
| Systane iLux2 (K200400) | Tear Film Innovations, Inc. | 2020-05-21 |
| Catalys Precision Laser System (K200056) | Amo Manufacturng USA, LLC | 2020-05-18 |
| PuriLens Plus Preservative Free Saline (K200747) | The Lifestyle Company, Inc. | 2020-05-15 |
| Icare HOME Tonometer (K200966) | Icare Finland OY | 2020-05-07 |
| iTEAR Neurostimulator (DEN190026) | Olympic Ophthalmics, Inc. | 2020-05-01 |
| Mydriatic Hyperspectral Retinal Camera (MHRC-C1) (K200254) | Optina Diagnostics | 2020-04-27 |
| Konan Specular Microscope XVII (K191558) | Konan Medical, Inc. | 2020-03-26 |
| 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 |
| Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (K191872) | Menicon Co, Ltd. | 2020-03-02 |
| Fundus Camera (K190954) | Chongqing Bio Newvision Medical Equipment , Ltd. | 2020-01-22 |
| RxSight Insertion Device (K192926) | Rxsight, Inc. | 2020-01-17 |
| Icare ic200 (K190316) | Icare Finland OY | 2020-01-14 |