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Ophthalmic

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

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RecordFirmDate
Ahmed Glaucoma Valve (K162060)New World Medical, Inc.2016-10-24
Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens (K162317)St. shine Optical Co., Ltd.2016-10-21
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (K162597)Alcon Laboratories, Inc.2016-10-19
AIR OPTIX COLORS (K162596)Alcon Laboratories, Inc.2016-10-13
Toricolors (hioxifilcon D) Soft Contact Lenses (K161931)Polydev , Ltd.2016-10-12
R:GEN Laser System (K153769)Lutronic Corporation2016-10-05
ALADDIN HW3.0 (K160327)Visia Imaging S.R.L.2016-10-05
Eyenez Ophthalmic Camera (K161727)Eyenez, LLC2016-10-04
Catalys Precision Laser System (K161455)Optimedica Corporation2016-09-20
EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear (K161124)Vision Science Co., Ltd.2016-08-26
ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) (K161098)Joowon Innovation Co., Ltd.2016-08-22
SACCADOMETER PLUS, SACCADOMETER ADVANCED (K152890)Ober Consulting Sp. Z.O.O.2016-08-11
LensGiene Sterile Saline Solution (K161622)Optics Laboratory, Inc.2016-08-11
Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses (K161100)Contamac, Ltd.2016-08-10
Hidrocor, Hidrocharme, and Natural Colors (K160472)Solotica2016-08-10
SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens (K160938)Synergeyes, Inc.2016-08-01
3D OCT-1 Maestro (K161509)Topcon Corporation2016-07-28
BostonSight PD Prosthetic Device (K161461)Bostonsight2016-07-25
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens (K160803)CooperVision, Inc.2016-07-13
OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (K160859)Contamac, Ltd.2016-07-13
PolyDev Soft Contact Lenses (K160977)Polydev , Ltd.2016-07-13
Easy-Load Lens Delivery System (K161012)Bausch and Lomb, Inc.,2016-07-06
Portable Slit Lamp (K153545)Shanghai Bolan Optical-Electric Co., Ltd.2016-06-22
LightLas Multi-Wavelength Medical Laser System (K152688)Lightmed Corporation2016-06-15
MAIA (K153181)Centervue S.P.A.2016-06-08
PEDIATRIC VISION SCANNER (DEN130051)Rebiscan, Inc.2016-06-08
Contact Lens Case (multiple brand name) (K160005)Danyang Chanxin Glasses Cases Factory2016-06-07
MICROPERIMETER MP-3 (K152729)Nidek Co., Ltd.2016-06-06
Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 (K160344)Visco Vision, Inc.2016-05-26
Z5 Slit lamp microscope, Z2 Slit lamp microscope (K152535)Takagi Seiko Co., Ltd.2016-05-26
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens (K152657)Smart Performer Corp. , Ltd.2016-05-17
LSFG-NAVI (K153239)Softcare Co., Ltd.2016-05-12
Slit Lamp Microscope (K152429)Shanghai Mediworks Precision Instruments Co. , Ltd.2016-05-11
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor (K152205)Heidelberg Engineering GmbH2016-05-06
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric (K160609)Alcon Laboratories, Inc.2016-05-02
Green Laser Photocoagulator GYC-500 (K152603)Nidek Co., Ltd.2016-05-02
Bi-Blade Vitrectomy Cutter (K153168)Medical Instrument Development Laboratories2016-04-29
EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES (K152724)Advanced Vision Technologies2016-04-27
Dual Pump Pack (K160236)Abbott Medical Optics, Inc.2016-04-27
GLAUCOMA COMPANION (DEN140022)Innovatex, Inc.2016-04-20
Icare ic100 (K153694)Icare Finland OY2016-04-19
Applanation Tonometer (K142263)Shanghai Mediworks Precision Instruments Co. , Ltd.2016-04-15
EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear (K153305)Eyeyon Medical2016-04-08
Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K153766)INTEROJO, Inc.2016-04-08
ACUVUE (senofilcon C) Soft Contact Lens (K160212)Johnson & Johnson Vision Care, Inc.2016-03-28
Specular Microscope CEM- 530 (K151706)Nidek Co., Ltd.2016-03-17
SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens (K151847)Smart Performer Corp. , Ltd.2016-03-04
SENSIMED TRIGGERFISH (DEN140017)Sensimed AG2016-03-04
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist (K151918)Bausch & Lomb, Incorporated2016-02-11
RTVue XR OCT Avanti with AngioVue Software (K153080)Optovue, Inc.2016-02-11
BostonSight IC Corneal Lens, BostonSight IC Scleral Lens (K153066)Boston Foundation For Sight2016-02-09
Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives (K153643)Alcon Laboratories, Inc.2016-01-20
Pentacam AXL (K152311)Oculus Optikgerate GmbH2016-01-20
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal (K153642)Alcon Laboratories, Inc.2016-01-20
Falck Medical Multifunction Tonometer, FAT1 (K151491)Falck Medical, Inc.2016-01-15
LipiView II Ocular Surface Interferometer (K152869)Tearscience, Inc.2016-01-14
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 (K152644)Keeler Limited2015-12-31
BrainPort V100 (K152851)Wicab, Inc.2015-12-24
Molteno3 Glaucoma Implant (K152996)Innovative Ophthalmic Products, Inc. (Iop)2015-12-17
EnFocus 2300, EnFocus 4400 (K150722)Bioptigen, Inc.2015-12-02
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) (K152046)Art Optical Contact Lens, Inc.2015-11-24
MicroSTAAR Injector System Cartridges (K152357)STAAR Surgical Company2015-10-30
FEMTO LDV Z8 Surgical Laser (K150323)Sie Ag,Surgical Instrument Engineering2015-10-23
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control (K151636)Abbott Medical Optics, Inc.2015-10-19
LENSAR Laser System - fs 3D (LLS-fs 3D) (K152453)Lensar, Inc.2015-10-15
Sensor Medical Single Use Tonometer Prism (K152308)Sensor Medical Technology, LLC2015-10-13
ARGOS (K150754)Santec Corporation2015-10-02
Keeler Slit Lamp (K151394)Keeler Limited2015-09-10
COMPACT INTUITIV Multiple-Use Pack (K151783)Abbott Medical Optics, Inc.2015-09-02
CIRRUS HD-OCT (K150977)Carl Zeiss Meditec, Inc.2015-09-01
Menicon Saline Rinse Solution (K151768)Menicon Co, Ltd.2015-08-28
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens (K151961)Volk Optical, Inc.2015-08-18
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants (K150986)Meddev Corporation2015-08-17
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens (K151586)Yung Sheng Optical Co., Ltd.2015-08-10
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow (K142398)Ellex Medical Pty, Ltd.2015-07-14
IOLMaster700 (K143275)Carl Zeiss Meditec, Inc.2015-07-10
CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, (K150590)Contamac, Ltd.2015-07-10
COMPASS (K150320)Centervue S.P.A.2015-06-30
Ophthalmed Bending Laser Probes (K142830)Ophthalmed, LLC2015-06-25
VICTUS Femtosecond Laser Platform (K151161)Technolas Perfect Vision GmbH2015-06-24
VISCO SOFT CONTACT LENS (K141348)Visco Vision, Inc.2015-06-22
BRAINPORT V100 DEVICE (DEN130039)Wicab, Inc.2015-06-18
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear (K150630)Yung Sheng Optical Co., Ltd.2015-06-15
VX120 Ophthalmic Diagnostic Device (K143086)Luneau Sas2015-06-01
SP-1PSpecular Microscope (K142417)Topcon Corporation2015-05-29
Bausch + Lomb Injector System (K151102)Bausch & Lomb, Inc.2015-05-22
HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 (K142486)Heine Optotechnik GmbH & Co. KG2015-05-18
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case (K142717)Ni Hau Industrial Co., Ltd.2015-05-07
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series (K143434)Abbott Medical Optics, Inc.2015-05-06
BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear (K142820)Abb Optical Group, LLC2015-04-30
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (K150385)Visioneering Technologies, Inc.2015-04-30
iCase Contact Lens Case (K143351)Novabay Pharmaceuticals, Inc.2015-04-29
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens (K143280)Brien Holden Vision Pty , Ltd.2015-04-23
EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) (K150293)I-See Vision Technology, Inc.2015-04-15
LIOLI IOL DELIVERY SYSTEM (K142056)Ast Products, Inc.2015-04-09
myVision Track Model 005 (K143211)Vital Art and Science Incorporated2015-03-20
LENSAR Laser System - fs 3D (K143010)Lensar, Inc.2015-03-20
EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) (K142877)Dutch Ophthalmic Research Center International BV2015-03-13
I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (K142766)INTEROJO, Inc.2015-03-12
OCT-Camera (K142953)Optomedical Technologies GmbH2015-03-04
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