Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 31
- Latest Decision
- 2016-11-21
Clearances · page 6 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | KYF | Class II | 2016-11-21 |
| K161288 | LenSX Laser System | Alcon Laboratories, Inc. | OOE | Class II | 2016-11-16 |
| K153714 | 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 | Synergeyes, Inc. | HQD | Class II | 2016-11-15 |
| K161357 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | ORZ | Class II | 2016-11-04 |
| K161194 | PLEX Elite 9000 SS-OCT | Carl Zeiss Meditec, Inc. | OBO | Class II | 2016-10-26 |
| K160245 | Visco (olifilcon A) soft contact lens | Visco Vision, Inc. | LPL | Class II | 2016-10-24 |
| K162060 | Ahmed Glaucoma Valve | New World Medical, Inc. | KYF | Class II | 2016-10-24 |
| K162317 | 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 | St. shine Optical Co., Ltd. | LPL | Class II | 2016-10-21 |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | LPN | Class II | 2016-10-19 |
| K162596 | AIR OPTIX COLORS | Alcon Laboratories, Inc. | LPL | Class II | 2016-10-13 |
| K161931 | Toricolors (hioxifilcon D) Soft Contact Lenses | Polydev , Ltd. | LPL | Class II | 2016-10-12 |
| K160327 | ALADDIN HW3.0 | Visia Imaging S.R.L. | HJO | Class II | 2016-10-05 |
| K153769 | R:GEN Laser System | Lutronic Corporation | HQF | Class II | 2016-10-05 |
| K161727 | Eyenez Ophthalmic Camera | Eyenez, LLC | HKI | Class II | 2016-10-04 |
| K161455 | Catalys Precision Laser System | Optimedica Corporation | OOE | Class II | 2016-09-20 |
| K161124 | EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear | Vision Science Co., Ltd. | LPL | Class II | 2016-08-26 |
| K161098 | ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) | Joowon Innovation Co., Ltd. | LPL | Class II | 2016-08-22 |
| K161622 | LensGiene Sterile Saline Solution | Optics Laboratory, Inc. | LPN | Class II | 2016-08-11 |
| K152890 | SACCADOMETER PLUS, SACCADOMETER ADVANCED | Ober Consulting Sp. Z.O.O. | HLL | Class II | 2016-08-11 |
| K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | Contamac, Ltd. | HQD | Class II | 2016-08-10 |
| K160472 | Hidrocor, Hidrocharme, and Natural Colors | Solotica | LPL | Class II | 2016-08-10 |
| K160938 | SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens | Synergeyes, Inc. | HQD | Class II | 2016-08-01 |
| K161509 | 3D OCT-1 Maestro | Topcon Corporation | OBO | Class II | 2016-07-28 |
| K161461 | BostonSight PD Prosthetic Device | Bostonsight | HQD | Class II | 2016-07-25 |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | CooperVision, Inc. | LPL | Class II | 2016-07-13 |
| K160977 | PolyDev Soft Contact Lenses | Polydev , Ltd. | LPL | Class II | 2016-07-13 |
| K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | Contamac, Ltd. | MUW | Class II | 2016-07-13 |
| K161012 | Easy-Load Lens Delivery System | Bausch and Lomb, Inc., | MSS | Class I | 2016-07-06 |
| K153545 | Portable Slit Lamp | Shanghai Bolan Optical-Electric Co., Ltd. | HJO | Class II | 2016-06-22 |
| K152688 | LightLas Multi-Wavelength Medical Laser System | Lightmed Corporation | HQF | Class II | 2016-06-15 |
| DEN130051 | PEDIATRIC VISION SCANNER | Rebiscan, Inc. | PMW | Class II | 2016-06-08 |
| K153181 | MAIA | Centervue S.P.A. | MYC | Class II | 2016-06-08 |
| K160005 | Contact Lens Case (multiple brand name) | Danyang Chanxin Glasses Cases Factory | LRX | Class II | 2016-06-07 |
| K152729 | MICROPERIMETER MP-3 | Nidek Co., Ltd. | HKI | Class II | 2016-06-06 |
| K160344 | 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 | Visco Vision, Inc. | LPL | Class II | 2016-05-26 |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | Takagi Seiko Co., Ltd. | HJO | Class II | 2016-05-26 |
| K152657 | SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens | Smart Performer Corp. , Ltd. | LPL | Class II | 2016-05-17 |
| K153239 | LSFG-NAVI | Softcare Co., Ltd. | HKI | Class II | 2016-05-12 |
| K152429 | Slit Lamp Microscope | Shanghai Mediworks Precision Instruments Co. , Ltd. | HJO | Class II | 2016-05-11 |
| K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor | Heidelberg Engineering GmbH | OBO | Class II | 2016-05-06 |
| K160609 | AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric | Alcon Laboratories, Inc. | LPL | Class II | 2016-05-02 |
| K152603 | Green Laser Photocoagulator GYC-500 | Nidek Co., Ltd. | HQF | Class II | 2016-05-02 |
| K153168 | Bi-Blade Vitrectomy Cutter | Medical Instrument Development Laboratories | HQE | Class II | 2016-04-29 |
| K160236 | Dual Pump Pack | Abbott Medical Optics, Inc. | HQC | Class II | 2016-04-27 |
| K152724 | EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES | Advanced Vision Technologies | HQD | Class II | 2016-04-27 |
| DEN140022 | GLAUCOMA COMPANION | Innovatex, Inc. | PLX | Class I | 2016-04-20 |
| K153694 | Icare ic100 | Icare Finland OY | HKY | Class II | 2016-04-19 |
| K142263 | Applanation Tonometer | Shanghai Mediworks Precision Instruments Co. , Ltd. | HKY | Class II | 2016-04-15 |
| K153305 | EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear | Eyeyon Medical | LPL | Class II | 2016-04-08 |
| K153766 | Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear | INTEROJO, Inc. | LPL | Class II | 2016-04-08 |
| K160212 | ACUVUE (senofilcon C) Soft Contact Lens | Johnson & Johnson Vision Care, Inc. | LPL | Class II | 2016-03-28 |
| K151706 | Specular Microscope CEM- 530 | Nidek Co., Ltd. | NQE | Class II | 2016-03-17 |
| K151847 | SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens | Smart Performer Corp. , Ltd. | LPL | Class II | 2016-03-04 |
| DEN140017 | SENSIMED TRIGGERFISH | Sensimed AG | PLZ | Class II | 2016-03-04 |
| K151918 | Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist | Bausch & Lomb, Incorporated | LPL | Class II | 2016-02-11 |
| K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | HLI | Class II | 2016-02-11 |
| K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | Boston Foundation For Sight | HQD | Class II | 2016-02-09 |
| K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | Alcon Laboratories, Inc. | LPL | Class II | 2016-01-20 |
| K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | Alcon Laboratories, Inc. | LPL | Class II | 2016-01-20 |
| K152311 | Pentacam AXL | Oculus Optikgerate GmbH | MXK | Class II | 2016-01-20 |
| K151491 | Falck Medical Multifunction Tonometer, FAT1 | Falck Medical, Inc. | HKY | Class II | 2016-01-15 |
| K152869 | LipiView II Ocular Surface Interferometer | Tearscience, Inc. | HKI | Class II | 2016-01-14 |
| K152644 | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 | Keeler Limited | HKY | Class II | 2015-12-31 |
| K152851 | BrainPort V100 | Wicab, Inc. | PIC | Class II | 2015-12-24 |
| K152996 | Molteno3 Glaucoma Implant | Innovative Ophthalmic Products, Inc. (Iop) | KYF | Class II | 2015-12-17 |
| K150722 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | HLI | Class II | 2015-12-02 |
| K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) | Art Optical Contact Lens, Inc. | LPL | Class II | 2015-11-24 |
| K152357 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | KYB | Class I | 2015-10-30 |
| K150323 | FEMTO LDV Z8 Surgical Laser | Sie Ag,Surgical Instrument Engineering | OOE | Class II | 2015-10-23 |
| K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control | Abbott Medical Optics, Inc. | HQC | Class II | 2015-10-19 |
| K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | OOE | Class II | 2015-10-15 |
| K152308 | Sensor Medical Single Use Tonometer Prism | Sensor Medical Technology, LLC | HKY | Class II | 2015-10-13 |
| K150754 | ARGOS | Santec Corporation | MXK | Class II | 2015-10-02 |
| K151394 | Keeler Slit Lamp | Keeler Limited | HJO | Class II | 2015-09-10 |
| K151783 | COMPACT INTUITIV Multiple-Use Pack | Abbott Medical Optics, Inc. | HQC | Class II | 2015-09-02 |
| K150977 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | OBO | Class II | 2015-09-01 |
| K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | LPN | Class II | 2015-08-28 |
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | Volk Optical, Inc. | HJK | Class II | 2015-08-18 |
| K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants | Meddev Corporation | MML | Class II | 2015-08-17 |
| K151586 | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens | Yung Sheng Optical Co., Ltd. | LPL | Class II | 2015-08-10 |
| K142398 | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow | Ellex Medical Pty, Ltd. | HQF | Class II | 2015-07-14 |
| K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | HJO | Class II | 2015-07-10 |
| K150590 | CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, | Contamac, Ltd. | LPL | Class II | 2015-07-10 |
| K150320 | COMPASS | Centervue S.P.A. | MYC | Class II | 2015-06-30 |
| K142830 | Ophthalmed Bending Laser Probes | Ophthalmed, LLC | HQF | Class II | 2015-06-25 |
| K151161 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | OOE | Class II | 2015-06-24 |
| K141348 | VISCO SOFT CONTACT LENS | Visco Vision, Inc. | LPL | Class II | 2015-06-22 |
| DEN130039 | BRAINPORT V100 DEVICE | Wicab, Inc. | PIC | Class II | 2015-06-18 |
| K150630 | 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 | Yung Sheng Optical Co., Ltd. | MVN | Class II | 2015-06-15 |
| K143086 | VX120 Ophthalmic Diagnostic Device | Luneau Sas | HKX | Class II | 2015-06-01 |
| K142417 | SP-1PSpecular Microscope | Topcon Corporation | NQE | Class II | 2015-05-29 |
| K151102 | Bausch + Lomb Injector System | Bausch & Lomb, Inc. | MSS | Class I | 2015-05-22 |
| K142486 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | Heine Optotechnik GmbH & Co. KG | HLJ | Class II | 2015-05-18 |
| K142717 | Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case | Ni Hau Industrial Co., Ltd. | LRX | Class II | 2015-05-07 |
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | Abbott Medical Optics, Inc. | MSS | Class I | 2015-05-06 |
| K142820 | 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 | Abb Optical Group, LLC | LPL | Class II | 2015-04-30 |
| K150385 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Visioneering Technologies, Inc. | LPL | Class II | 2015-04-30 |
| K143351 | iCase Contact Lens Case | Novabay Pharmaceuticals, Inc. | LRX | Class II | 2015-04-29 |
| K143280 | BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens | Brien Holden Vision Pty , Ltd. | LPL | Class II | 2015-04-23 |
| K150293 | EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) | I-See Vision Technology, Inc. | LPL | Class II | 2015-04-15 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.