Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 32
- Latest Decision
- 2022-06-17
Clearances · page 3 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K213037 | IDx-DR v2.3 | Digital Diagnostics, Inc. | PIB | Class II | 2022-06-17 |
| K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | HQC | Class II | 2022-06-14 |
| K220259 | ALLY Adaptive Cataract Treatment System | Lensar, Inc. | OOE | Class II | 2022-06-09 |
| K220516 | CATALYS Precision Laser system | Amo Manufacturing USA, LLC | OOE | Class II | 2022-05-17 |
| K213119 | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | Innova Vision, Inc. | LPL | Class II | 2022-05-13 |
| K220430 | Capsulo | Quantel Medical | HQF | Class II | 2022-05-12 |
| K220030 | Vista Ophthalmics Vitrectomy Probe | Vista Ophthalmics, LLC | MLZ | Class II | 2022-05-04 |
| DEN200063 | Kerasave | Al.Chi.Mi.A. S.R.L | QCW | Class II | 2022-05-02 |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | OBO | Class II | 2022-04-27 |
| K213559 | FEMTO LDV Z8 Femtosecond Surgical Laser | Sie Ag,Surgical Instrument Engineering | OOE | Class II | 2022-04-21 |
| K212241 | QUATERA 700 | Carl Zeiss Meditec, AG | HQC | Class II | 2022-04-19 |
| K213592 | Iridex 810 Laser | Iridex Corporation | HQF | Class II | 2022-03-23 |
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | Contamac, Ltd. | HQD | Class II | 2022-03-17 |
| K213623 | iTEAR100 Neurostimulator | Olympic Ophthalmics | QKV | Class II | 2022-03-16 |
| K211868 | MYAH | Visia Imaging S.R.L. | MXK | Class II | 2022-03-01 |
| K211617 | Infrascanner | Infrascan, Inc. | OPT | Class II | 2022-02-09 |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | LPL | Class II | 2022-02-04 |
| K203586 | EndoSerter-PL | Corneagen, Inc. | OTZ | Class I | 2022-02-02 |
| K211603 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | 2022-02-02 |
| K211355 | iCare HOME2 | Icare Finland OY | HKY | Class II | 2022-01-25 |
| K213216 | Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens | Unicon Optical Co., Ltd. | LPL | Class II | 2022-01-18 |
| K211361 | 3N Contact Lenses Adjunct Cleaner | Suzhou 3N Biological Technology Co., Ltd. | LYL | Class II | 2022-01-13 |
| K213880 | Custom Stable Rigid Gas Permeable Scleral Contact Lens | Valley Contax, Inc. | HQD | Class II | 2022-01-07 |
| K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | HQD | Class II | 2021-12-30 |
| K212806 | Alcon (serafilcon A) soft contact lenses for daily wear | Alcon Laboratories, Inc. | LPL | Class II | 2021-12-28 |
| K213045 | TearCare System | Sight Sciences, Inc. | ORZ | Class II | 2021-12-21 |
| K213705 | DRSplus | Centervue S.P.A. | MYC | Class II | 2021-12-21 |
| K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | Ellex Medical Pty, Ltd. | HQF | Class II | 2021-12-16 |
| K210827 | ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. | PUL | Class II | 2021-12-14 |
| K211448 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | 2021-12-06 |
| K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | Johnson & Johnson Vision Care, Inc. | LPL | Class II | 2021-11-29 |
| K211817 | Anterion | Heidelberg Engineering GmbH | OBO | Class II | 2021-11-05 |
| K213164 | Avaira Vitality | CooperVision, Inc. | LPL | Class II | 2021-10-26 |
| DEN210005 | Luminopia One | Luminopia, Inc. | QQU | Class II | 2021-10-20 |
| K212039 | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories, Inc. | MSS | Class I | 2021-08-23 |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Centervue S.P.A. | MYC | Class II | 2021-08-19 |
| K202989 | Myopia Master | Oculus Optikgeräte GmbH | MXK | Class II | 2021-07-14 |
| K203850 | CATS®-D Tonometer Prism | Cats Tonometer, LLC | HKY | Class II | 2021-06-14 |
| K203569 | Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants | Fci (France Chirurgie Instrumentation) Sas | NCB | Class II | 2021-06-11 |
| K203629 | IDx-DR | Digital Diagnostics, Inc. | PIB | Class II | 2021-06-10 |
| K202932 | ABT12 multi-purpose solution | Bausch & Lomb, Incorporated | LPN | Class II | 2021-05-28 |
| K210051 | OTE MPS 045 Multi-purpose Lens Care Solution | Ote North America, LLC | LPN | Class II | 2021-05-26 |
| K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | Bausch & Lomb, Incorporated | LPL | Class II | 2021-05-24 |
| K202860 | 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) | Valley Contax, Inc. | HQD | Class II | 2021-05-11 |
| K210609 | AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens | Vp Optics | LPL | Class II | 2021-04-27 |
| K210197 | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | HKI | Class II | 2021-04-13 |
| K203500 | RetCam Envision | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | HKI | Class II | 2021-04-13 |
| K210436 | Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere | Alcon Laboratories, Inc. | LPL | Class II | 2021-04-12 |
| K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | HQD | Class II | 2021-04-09 |
| K210701 | CATALYS Precision Laser System | Amo Manufacturing USA, LLC | OOE | Class II | 2021-04-07 |
| K210300 | VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System | Vuesonic, LLC | LYL | Class II | 2021-04-01 |
| K202129 | 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 | Largan Medical Co., Ltd. | LPL | Class II | 2021-04-01 |
| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control | Johnson & Johnson Surgical Vision, Inc. | HQC | Class II | 2021-03-12 |
| DEN200028 | Lumenis Stellar M22 | Lumenis, Ltd. | QIU | Class II | 2021-02-23 |
| K202097 | Fundus Camera | Huvitz Co., Ltd. | HKI | Class II | 2021-02-02 |
| K202221 | VX650 | Luneau Technology Operations | HKI | Class II | 2021-01-29 |
| K202038 | CryoTreQ | VitreQ BV | HPS | Class II | 2020-12-30 |
| K200618 | HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens | Visco Vision, Inc. | LPL | Class II | 2020-12-07 |
| K203130 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | HQF | Class II | 2020-12-07 |
| K201325 | Optomed Smartscope M5 with Optomed Smartscope FA | Optomed Oyj | HKI | Class II | 2020-11-20 |
| K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | MXK | Class II | 2020-10-21 |
| K201268 | Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | Plexus Optix, Inc. | LPL | Class II | 2020-10-21 |
| K202760 | Iridex 810 Laser | Iridex Corporation | HQF | Class II | 2020-10-21 |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) | CooperVision, Inc. | LPL | Class II | 2020-10-20 |
| K200207 | xPORT S Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | HQC | Class II | 2020-10-15 |
| K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | 2020-10-15 |
| DEN200002 | Tangible Boost | Tangible Science, Inc. | QMM | Class II | 2020-09-24 |
| K200416 | Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | MRC | Class II | 2020-09-23 |
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Alcon Laboratories, Inc. | MVN | Class II | 2020-09-22 |
| K201013 | Optixon 1-Day | Optixon, Inc. | LPL | Class II | 2020-09-18 |
| K201909 | RxSight Contact Lens | Rxsight, Inc. | HJK | Class II | 2020-09-10 |
| K201252 | Spectralis HRA+OCT and variants | Heidelberg Engineering GmbH | OBO | Class II | 2020-09-09 |
| K201194 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | HQD | Class II | 2020-09-08 |
| K200516 | OCT-Camera ID 21101A3 | Optomedical Technologies GmbH | OBO | Class II | 2020-09-02 |
| K200724 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | OOE | Class II | 2020-09-01 |
| K193589 | TrueTear Intranasal Tear Neurostimulator | Allergan | QBR | Class II | 2020-08-31 |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Alcon Laboratories, Inc. | MVN | Class II | 2020-08-21 |
| K201623 | LION Photocoagulator | Norlase Aps | HQF | Class II | 2020-08-11 |
| K201502 | Vitra 810 | Quantel Medical | HQF | Class II | 2020-08-06 |
| K200667 | EyeArt | Eyenuk, Inc. | PIB | Class II | 2020-08-03 |
| K201069 | VibrantVue Scleral Saline | Dry Eye Innovations, LLC | MRC | Class II | 2020-07-31 |
| K200584 | xPORT 304 (miCOR) System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | HQC | Class II | 2020-07-31 |
| K201122 | Canon non-mydriatic retinal camera CR series | Canon, Inc. | HKI | Class II | 2020-07-23 |
| K201080 | 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 | Visco Vision, Inc. | LPL | Class II | 2020-07-15 |
| K200203 | Infrascanner | Infrascan, Inc. | OPT | Class II | 2020-07-10 |
| K193399 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | LPL | Class II | 2020-06-17 |
| K193376 | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | HQC | Class II | 2020-06-15 |
| K200057 | bioli lOL Delivery System | Ast Products, Inc. | MSS | Class I | 2020-06-04 |
| K200528 | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism | Bausch + Lomb, Incorporated | LPL | Class II | 2020-06-02 |
| K200911 | MIRA Adapter | Phakos | HRN | Class II | 2020-06-02 |
| K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | Vasoptic Medical, Inc. | HKI | Class II | 2020-06-01 |
| K192418 | Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico, LLC | HQC | Class II | 2020-05-27 |
| K193441 | Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. | LPN | Class II | 2020-05-26 |
| K200400 | Systane iLux2 | Tear Film Innovations, Inc. | ORZ | Class II | 2020-05-21 |
| K200056 | Catalys Precision Laser System | Amo Manufacturng USA, LLC | OOE | Class II | 2020-05-18 |
| K200747 | PuriLens Plus Preservative Free Saline | The Lifestyle Company, Inc. | LPN | Class II | 2020-05-15 |
| K200966 | Icare HOME Tonometer | Icare Finland OY | HKY | Class II | 2020-05-07 |
| DEN190026 | iTEAR Neurostimulator | Olympic Ophthalmics, Inc. | QKV | Class II | 2020-05-01 |
| K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Optina Diagnostics | HKI | Class II | 2020-04-27 |
| K191558 | Konan Specular Microscope XVII | Konan Medical, Inc. | NQE | Class II | 2020-03-26 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.