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Ophthalmic

4,750 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
MiiS Horus Eye Anterior Camera (K193188)Medimaging Integrated Solution, Inc (Miis)2020-01-14
MAXReach Laser Probe (K191846)Vortex Surgical, Inc.2019-12-23
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (K191314)Chongqing Sunkingdom Medical Instrument Co., Ltd.2019-12-19
Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses (K192225)Vizionfocus, Inc.2019-12-09
Intraocular Pressure Tonometer EASYTON (K190382)Company Elamed2019-12-06
DRSplus (K192113)Centervue S.P.A.2019-11-15
Ophthalmic Yag Laser System YC-200 (K192045)Nidek Co., Ltd.2019-11-15
LEGION System (K191650)Alcon Research, LLC2019-11-01
LipiFlow Thermal Pulsation System (K192623)Tearscience, Inc.2019-10-22
Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005)Bausch & Lomb, Inc.2019-10-04
OxySoft (olifilcon C) silicone hydrogel soft contact lens (K191397)Visco Vision, Inc.2019-10-02
ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens (K192129)Clearlab SG Pte, Ltd.2019-09-27
Spectralis HRA+OCT and Variants (K192391)Heidelberg Engineering GmbH2019-09-26
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) (K190875)D.O.R.C. Dutch Ophthalmic Research Center (International)2019-09-25
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K191929)Unicon Optical Co., Ltd.2019-09-17
Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens (K183670)Visco Vision, Inc.2019-09-13
UNFOLDER Vitan Inserter (K191949)Johnson & Johnson Surgical Vision, Inc.2019-09-13
KOWA nonmyd 8 (K191945)Kowa Company , Ltd.2019-09-10
Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens (K191121)Lentechs, LLC2019-09-06
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal (K191933)Johnson & Johnson Surgical Vision, Inc.2019-08-16
xPORT Lens Fragmentation System (K191024)Carl Zeiss Meditec Cataract Technology, Inc.2019-08-13
REFRESH RELIEVA For CONTACTS (K190674)Allergan, Inc.2019-08-08
AOCup Lens Case with AODisc (K191795)Alcon Laboratories, Inc.2019-07-31
P200TxE (K190732)Optos Plc.2019-07-31
Galilei G6 Lens Professional (K182659)Sis Ag, Surgical Instrument Systems2019-07-25
Canon OCT-A1 (K182942)Canon, Inc.2019-07-24
MaxiTears Contacts PF (K182984)Omnivision AG2019-07-24
CLARUS (K191194)Carl Zeiss Meditec, Inc.2019-06-25
MiiS Horus Scope DPT 100 (K181260)Medimaging Integrated Solution, Inc (Miis)2019-06-21
KOWA DR-1a (K190573)Kowa Company , Ltd.2019-06-04
LightLas Pattern Scanning System - TruScan Pro (K190448)Light-Med(Usa), Inc.2019-05-24
ARGOS (K191051)Santec Corporation2019-05-16
Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac (K182734)Unicon Optical Co., Ltd.2019-05-16
Leaf Photocoagulator (K190083)Norlase Aps2019-05-03
Vitreq disposable laser probes, light fibers and Chandelier (K182646)VitreQ BV2019-05-01
MyDay (K190965)CooperVision, Inc.2019-04-29
Microperimeter MP-3, Microperimeter MP-3 Type S (K190198)Nidek Co., Ltd.2019-04-01
BL-Cart IOL Delivery Cartridge (K182965)Ast Products, Inc.2019-03-29
VISULAS green (K181682)Carl Zeiss Meditec, AG2019-03-06
ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) (K181656)Eyemed Technologies S.R.L.2019-03-05
CIRRUS HD-OCT (K181534)Carl Zeiss Meditec, Inc.2019-02-15
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens (K183167)Bausch & Lomb, Incorporated2019-02-12
Keeler TonoCare Tonometer (K181143)Keeler Instruments, Inc.2019-02-08
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives (K190045)Alcon Laboratories, Inc.2019-02-06
Boston Keratoprosthesis, Type I Lucia (K182986)Massachusetts Eye and Ear Infirmary D/B/A Boston2019-01-30
AHMED ClearPath Glaucoma Drainage Device (K182518)New World Medical, Inc.2019-01-18
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric (K182782)Alcon Laboratories, Inc.2019-01-18
RESCAN 700, CALLISTO eye (K180229)Carl Zeiss Meditec, AG2019-01-11
CLARUS (K181444)Carl Zeiss Meditec, Inc.2019-01-10
iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses (K183200)C&E GP Specialist, Inc.2019-01-09
BostonSight Scleral (K183175)Bostonsight2019-01-04
NFC-700 non-mydriatic auto fundus camera (K182199)Crystalvue Medical Corporation2019-01-02
LENSAR Laser System - fs 3D (LLS-fs 3D) (K182795)Lensar, Inc.2018-12-21
3nethra neo (K183059)Forus Health Pvt.Ltd2018-12-21
Tono Vue Non-Contact Tonometer (K180820)Crystalvue Medical Corporation2018-12-14
Precision1 (K182902)Alcon Laboratories, Inc.2018-12-11
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (K181920)CooperVision, Inc.2018-12-11
Applanation tonometer AT-2 (K182491)Takagi Seiko Co., Ltd.2018-12-10
LipiScan Dynamic Meibomian Imager (K182506)Tearscience, Inc.2018-12-10
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens (K182249)Bausch & Lomb, Incorporated2018-11-30
Hyper GP (tisilfocon A) Daily Wear Contact Lens (K182304)Contamac, Ltd.2018-11-23
Sunkingdom Slit Lamp (K182306)Chongqing Sunkingdom Medical Instrument Co., Ltd.2018-11-22
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal (K181454)Alcon Laboratories, Inc.2018-11-21
Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (K182674)Largan Medical Co., Ltd.2018-11-13
Catalys Precision Laser System (K182083)Amo Manufacturing USA, LLC2018-11-09
Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K182523)Largan Medical Co., Ltd.2018-11-01
Endocular Viewing Lenses and Silicone Ring (K173944)Phakos2018-10-25
Nutrifill (K181566)Contamac, Ltd.2018-10-22
Spectralis HRA+OCT and variants with High Magnification Module (K182569)Heidelberg Engineering GmbH2018-10-18
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) (K182247)Vizionfocus, Inc.2018-10-12
Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens (K181349)Visco Vision, Inc.2018-09-19
Spectralis HRA+OCT and variants with OCT Angiography Module (K181594)Heidelberg Engineering GmbH2018-09-13
RetCam 3 ; RetCam Shuttle ; RetCam Portable (K182263)Natus Medical Incorporated2018-09-07
Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens (K181558)Gelflex Laboratories2018-09-06
Spectralis HRA + OCT and variants (K173648)Heidelberg Engineering GmbH2018-08-30
IOLMaster 700 (K173771)Carl Zeiss Meditec, AG2018-08-24
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner (K181627)Bausch & Lomb, Incorporated2018-08-10
LENSAR Laser System - fs 3D (LLS-fs 3D) (K181430)Lensar, Inc.2018-08-09
FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions (K181796)Alcon Laboratories, Inc.2018-08-03
RetiCapture (K173474)Ilooda Co,., Ltd.2018-07-27
RxSight Insertion Device (K181401)Rxsight, Inc.2018-07-26
eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K (K181579)E&E Optics, Inc.2018-07-26
EIDON FA (K180526)Centervue S.P.A.2018-07-16
Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (K181232)Largan Medical Co., Ltd.2018-06-29
Alleye (K180895)Oculocare Medical AG2018-06-27
Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA (K181230)Largan Medical Co., Ltd.2018-06-25
Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) (K181050)Qualimed Srl2018-06-13
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (K180988)Acuity Polymers, Inc.2018-06-08
Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses (K180985)Supervision Optimax Sdn Bhd2018-06-08
Nexy (K180306)Next Sight Srl2018-06-08
Avanti (K180660)Optovue, Inc.2018-06-08
AT 030 (K180839)Carl Zeiss Meditec, AG2018-06-07
Retia 2 (K180293)Centervue S.P.A.2018-05-30
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar (K180402)Topcon Medical Laser Systems, Inc.2018-05-25
TrueTear Intranasal Tear Neurostimulator (DEN170086)Allergan2018-05-17
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens (K180819)Menicon Co, Ltd.2018-05-16
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal (K180669)Alcon Laboratories, Inc.2018-04-27
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens (K180616)Contamac, Ltd.2018-04-25
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens (K180322)Visco Vision, Inc.2018-04-20
VisuMax Femtosecond Laser (K173371)Carl Zeiss Meditec, Inc.2018-04-13
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