| IDx-DR (DEN180001) | Idx, LLC | 2018-04-11 |
| Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal (K180398) | Alcon Laboratories, Inc. | 2018-04-10 |
| ACUVUE OASYS (senofilcon A) with Photochromic Additive (K180299) | Johnson & Johnson Vision Care, Inc. | 2018-04-10 |
| Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module (K180378) | Optomed OY | 2018-04-05 |
| OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens (K173958) | Visco Vision, Inc. | 2018-04-03 |
| LenSx Laser System (K173660) | Alcon Laboratories, Inc. | 2018-03-27 |
| Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution (K180319) | Bausch and Lomb, Incorporated | 2018-03-27 |
| Frigitronics adapter (K180195) | Phakos | 2018-03-16 |
| FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG (K180172) | Paragon Vision Sciences | 2018-03-16 |
| Specular Microscope CEM-530 (K173980) | Nidek Co., Ltd. | 2018-03-14 |
| CATS Tonometer Prism (K173904) | Cats Tonometer, LLC | 2018-03-09 |
| LENSAR Laser System - fs 3D (LLS-fs 3D) (K173346) | Lensar, Inc. | 2018-03-02 |
| P200TE (K173707) | Optos Plc. | 2018-02-28 |
| Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens (K180004) | Menicon Co, Ltd. | 2018-02-22 |
| DRI OCT Triton (K173119) | Topcon Corporation | 2018-01-19 |
| EM-4000 Specular Microscope (K171313) | Tomey Corporation | 2018-01-19 |
| iLux Instrument, iLux Disposable (K172645) | Tear Film Innovations, Inc. | 2017-12-26 |
| SLM-1ER, SLM-2ER, SLM-3ER (K171877) | Chongqing Kanghua Ruiming S&T Co., Ltd. | 2017-12-21 |
| pioli IOL Delivery System (K172228) | Ast Products, Inc. | 2017-12-15 |
| Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens (K172692) | Tangible Science, LLC | 2017-12-13 |
| Crystalsert Lens Delivery System (K173480) | Bausch & Lomb, Inc. | 2017-12-11 |
| OxyPure Color Silicone Hydrogel Soft Contact Lenses (K171447) | Visco Vision, Inc. | 2017-12-05 |
| Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (K173538) | Alcon Laboratories, Inc. | 2017-12-04 |
| Contact Lens Case, Model: A-1, B-1 (K172925) | P L Overseas Limited | 2017-11-30 |
| PSLT for PASCAL Streamline (K171488) | Topcon Medical Laser Systems, Inc. | 2017-11-27 |
| Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions (K173089) | Bausch & Lomb, Incorporated | 2017-11-27 |
| Bausch + Lomb Boston Scleral Lens Case (K173365) | Bausch & Lomb, Incorporated | 2017-11-17 |
| Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (K173136) | Menicon Co, Ltd. | 2017-11-16 |
| NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (K173086) | Visioneering Technologies, Inc. | 2017-11-07 |
| Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor (K172649) | Heidelberg Engineering GmbH | 2017-11-01 |
| EPI K Console (K172994) | Moria SA | 2017-10-26 |
| AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal (K172600) | Alcon Laboratories, Inc. | 2017-10-25 |
| ENFLU 18 (enflufocon A) Daily Wear Contact Lens (K171575) | Contamac, Ltd. | 2017-10-24 |
| VICTUS Femtosecond Laser Platform (K171014) | Technolas Perfect Vision GmbH | 2017-10-19 |
| Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens (K171125) | Tangible Science, LLC | 2017-10-18 |
| Applanation tonometer AT-1 (K172728) | Takagi Seiko Co., Ltd. | 2017-10-17 |
| Digital Eye Anterior Camera (K170470) | Medimaging Integrated Solution, Inc (Miis) | 2017-10-06 |
| Cetus system, Cetus probe (K170183) | A.R.C Laser GmbH | 2017-09-27 |
| Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) (K172314) | Art Optical Contact Lens, Inc. | 2017-09-20 |
| Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA (K170286) | Largan Medical Co., Ltd. | 2017-09-18 |
| Phoenix Clinical ICON (K170527) | Phoenix Technology Group, Inc. Dba Phoenix Clinical | 2017-09-15 |
| MicroSTAAR Injector System Cartridges (K172375) | STAAR Surgical Company | 2017-09-06 |
| Catalys Precision Laser System (K172002) | Amo Manufacturing USA, LLC | 2017-08-25 |
| Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) (K171950) | Visionary Optics, LLC | 2017-08-16 |
| LENSAR Laser System – fs 3D (LLS-fs 3D) (K171337) | Lensar, Inc. | 2017-08-10 |
| DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal (K172066) | Alcon Laboratories, Inc. | 2017-08-09 |
| Ahmed Glaucoma Valve Model FP8 (K171451) | New World Medical, Inc. | 2017-08-08 |
| HEXA100 (hexafocon A) Daily Wear Contact Lenses (K171077) | Contamac, Ltd. | 2017-08-01 |
| Easyret (K170067) | Quantel Medical | 2017-07-25 |
| Portable Slit Lamp Microscope (K162778) | Suzhou Kangjie Medical, Inc. | 2017-07-21 |
| BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) (K171404) | Bausch + Lomb, Incorporated | 2017-07-17 |
| Contact Lens Case (K171539) | E-Link Plastic & Metal Industrial Co.,Ltd | 2017-07-14 |
| Contact Lens Case Round Glasses (K171163) | Fiftytwoways, Ltd. | 2017-06-27 |
| YELLOW LASER PHOTOCOAGULATOR YLC-500 (K170302) | Nidek Co., Ltd. | 2017-06-23 |
| PRIMUS (K163195) | Carl Zeiss Suzhou Co., Ltd. | 2017-06-21 |
| Katalyst Cyclophotocoagulation Probe (K163632) | Katalyst Surgical, LLC | 2017-06-15 |
| iVue (K163475) | Optovue, Inc. | 2017-06-09 |
| Altomed Malhotra Platinum Segments (K170591) | Altomed Limited | 2017-06-06 |
| Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens (K170001) | Acuity Polymers, Inc. | 2017-06-02 |
| Zepto (K170655) | Mynosys Cellular Devices, Inc. | 2017-06-02 |
| PolyDev Soft Contact Lenses (K171157) | Polydev , Ltd. | 2017-06-02 |
| SL 220 (K162684) | Carl Zeiss Meditec, AG | 2017-05-31 |
| Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens (K170007) | Acuity Polymers, Inc. | 2017-05-31 |
| SLIT LAMP SL-2000 (K163564) | Nidek Co., Ltd. | 2017-05-19 |
| Catalys Precision Laser System (K170322) | Abbott Medical Optics, Inc. | 2017-05-19 |
| LENSAR Laser System - fs 3D (LLS-fs 3D) (K170576) | Lensar, Inc. | 2017-05-05 |
| PHAKOS Disposable Retinal Cryo Probe (K162756) | Phakos | 2017-05-03 |
| Oculeve Intranasal Tear Neurostimulator Device (DEN160030) | Oculeve, Inc. | 2017-04-24 |
| VX130 Ophthalmic Diagnostic Device (K162067) | Luneau Sas | 2017-04-24 |
| Stellaris Elite vision enhancement system (K170052) | Bausch+Lomb | 2017-04-19 |
| CENTURION Vision System (Active SentryTM) (K161794) | Alcon Research, Ltd. | 2017-04-14 |
| Marco Ultra M3, Marco Ultra M4 (K162636) | Takagi Seiko Co., Ltd. | 2017-04-14 |
| HAAG-STREIT FUNDUS MODULE 300 (K163021) | Optomed OY | 2017-04-11 |
| Bausch + Lomb Sensitive Eyes Plus Saline Solution (K170483) | Bausch & Lomb, Incorporated | 2017-04-11 |
| IOLMaster 700 (K170171) | Carl Zeiss Meditec, AG | 2017-04-06 |
| Stellaris Elite Vision Enhancement System (K162342) | Bausch+Lomb | 2017-03-24 |
| Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens (K170335) | Valley Contax, Inc. | 2017-03-24 |
| HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (K170520) | Alcon Research, Ltd. | 2017-03-22 |
| Icare HOME tonometer (K163343) | Icare Finland OY | 2017-03-21 |
| 3D OCT-1 Maestro (K170164) | Topcon Corporation | 2017-03-03 |
| VISULUX (K161607) | Carl Zeiss Meditec, AG | 2017-02-23 |
| SLIT LAMP, Model: YF-100 (K161764) | Chongqing Yeasn Science-Technology Co., Ltd. | 2017-02-16 |
| LenSx Laser System (K163551) | Alcon Laboratories, Inc. | 2017-02-03 |
| D.O.R.C. Disposable Cryo Probe (K160591) | Dutch Ophthalmic Research Center International BV | 2017-01-23 |
| Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens (K163254) | Acuity Polymers, Inc. | 2017-01-18 |
| Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) (K162223) | Supervision Optimax Sdn Bhd | 2017-01-04 |
| Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (K161739) | Pegavision Corporation | 2016-12-19 |
| EnFocus 2300, EnFocus 4400 (K162783) | Bioptigen, Inc. | 2016-12-09 |
| Slit Lamp SL-D301 (K161972) | Topcon Corporation | 2016-12-09 |
| Contact Lens Case (K162869) | Ningbo Yinzhou Zonghai Artware Co., Ltd. | 2016-12-09 |
| Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (K162005) | Acuity Polymers, Inc. | 2016-12-08 |
| DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives (K161391) | Alcon Laboratories, Inc. | 2016-11-30 |
| Lenstec LC Injection system (K161776) | Lenstec, Inc. | 2016-11-29 |
| NNR06 Multi-Purpose Solution (K161819) | Bausch & Lomb, Incorporated | 2016-11-25 |
| XEN Glaucoma Treatment System (K161457) | Allergan, Inc. | 2016-11-21 |
| LenSX Laser System (K161288) | Alcon Laboratories, Inc. | 2016-11-16 |
| SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co (K153714) | Synergeyes, Inc. | 2016-11-15 |
| LipiFlow Thermal Pulsation System (K161357) | Tearscience, Inc. | 2016-11-04 |
| PLEX Elite 9000 SS-OCT (K161194) | Carl Zeiss Meditec, Inc. | 2016-10-26 |
| Visco (olifilcon A) soft contact lens (K160245) | Visco Vision, Inc. | 2016-10-24 |