Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 23
- Latest Decision
- 2020-03-23
Clearances · page 4 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC | CooperVision, Inc. | LPL | Class II | 2020-03-23 |
| K200243 | ACUVUE (senofilcon A) Soft Contact Lens Multifocal | Johnson & Johnson Vision Care, Inc. | LPL | Class II | 2020-03-17 |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Menicon Co, Ltd. | LPN | Class II | 2020-03-02 |
| K190954 | Fundus Camera | Chongqing Bio Newvision Medical Equipment , Ltd. | HKI | Class II | 2020-01-22 |
| K192926 | RxSight Insertion Device | Rxsight, Inc. | MSS | Class I | 2020-01-17 |
| K190316 | Icare ic200 | Icare Finland OY | HKY | Class II | 2020-01-14 |
| K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | HJO | Class II | 2020-01-14 |
| K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | HQB | Class II | 2019-12-23 |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co., Ltd. | HKY | Class II | 2019-12-19 |
| K192225 | Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses | Vizionfocus, Inc. | LPL | Class II | 2019-12-09 |
| K190382 | Intraocular Pressure Tonometer EASYTON | Company Elamed | HKX | Class II | 2019-12-06 |
| K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | HQF | Class II | 2019-11-15 |
| K192113 | DRSplus | Centervue S.P.A. | MYC | Class II | 2019-11-15 |
| K191650 | LEGION System | Alcon Research, LLC | HQC | Class II | 2019-11-01 |
| K192623 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | ORZ | Class II | 2019-10-22 |
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. | MSS | Class I | 2019-10-04 |
| K191397 | OxySoft (olifilcon C) silicone hydrogel soft contact lens | Visco Vision, Inc. | LPL | Class II | 2019-10-02 |
| K192129 | ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens | Clearlab SG Pte, Ltd. | LPL | Class II | 2019-09-27 |
| K192391 | Spectralis HRA+OCT and Variants | Heidelberg Engineering GmbH | OBO | Class II | 2019-09-26 |
| K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) | D.O.R.C. Dutch Ophthalmic Research Center (International) | HQC | Class II | 2019-09-25 |
| K191929 | UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | Unicon Optical Co., Ltd. | LPL | Class II | 2019-09-17 |
| K183670 | 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 | Visco Vision, Inc. | LPL | Class II | 2019-09-13 |
| K191949 | UNFOLDER Vitan Inserter | Johnson & Johnson Surgical Vision, Inc. | MSS | Class I | 2019-09-13 |
| K191945 | KOWA nonmyd 8 | Kowa Company , Ltd. | HKI | Class II | 2019-09-10 |
| K191121 | 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 | Lentechs, LLC | LPL | Class II | 2019-09-06 |
| K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal | Johnson & Johnson Surgical Vision, Inc. | HQC | Class II | 2019-08-16 |
| K191024 | xPORT Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | HQC | Class II | 2019-08-13 |
| K190674 | REFRESH RELIEVA For CONTACTS | Allergan, Inc. | LPN | Class II | 2019-08-08 |
| K191795 | AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | LPN | Class II | 2019-07-31 |
| K190732 | P200TxE | Optos Plc. | OBO | Class II | 2019-07-31 |
| K182659 | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | MXK | Class II | 2019-07-25 |
| K182984 | MaxiTears Contacts PF | Omnivision AG | MRC | Class II | 2019-07-24 |
| K182942 | Canon OCT-A1 | Canon, Inc. | OBO | Class II | 2019-07-24 |
| K191194 | CLARUS | Carl Zeiss Meditec, Inc. | QER | Class II | 2019-06-25 |
| K181260 | MiiS Horus Scope DPT 100 | Medimaging Integrated Solution, Inc (Miis) | HKX | Class II | 2019-06-21 |
| K190573 | KOWA DR-1a | Kowa Company , Ltd. | HKI | Class II | 2019-06-04 |
| K190448 | LightLas Pattern Scanning System - TruScan Pro | Light-Med(Usa), Inc. | HQF | Class II | 2019-05-24 |
| K191051 | ARGOS | Santec Corporation | MXK | Class II | 2019-05-16 |
| K182734 | Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac | Unicon Optical Co., Ltd. | LPL | Class II | 2019-05-16 |
| K190083 | Leaf Photocoagulator | Norlase Aps | HQF | Class II | 2019-05-03 |
| K182646 | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | HQB | Class II | 2019-05-01 |
| K190965 | MyDay | CooperVision, Inc. | LPL | Class II | 2019-04-29 |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | Nidek Co., Ltd. | HKI | Class II | 2019-04-01 |
| K182965 | BL-Cart IOL Delivery Cartridge | Ast Products, Inc. | MSS | Class I | 2019-03-29 |
| K181682 | VISULAS green | Carl Zeiss Meditec, AG | HQF | Class II | 2019-03-06 |
| K181656 | ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) | Eyemed Technologies S.R.L. | LPL | Class II | 2019-03-05 |
| K181534 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | OBO | Class II | 2019-02-15 |
| K183167 | 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 | Bausch & Lomb, Incorporated | HQD | Class II | 2019-02-12 |
| K181143 | Keeler TonoCare Tonometer | Keeler Instruments, Inc. | HKX | Class II | 2019-02-08 |
| K190045 | DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives | Alcon Laboratories, Inc. | LPL | Class II | 2019-02-06 |
| K182986 | Boston Keratoprosthesis, Type I Lucia | Massachusetts Eye and Ear Infirmary D/B/A Boston | HQM | Class II | 2019-01-30 |
| K182518 | AHMED ClearPath Glaucoma Drainage Device | New World Medical, Inc. | KYF | Class II | 2019-01-18 |
| K182782 | DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric | Alcon Laboratories, Inc. | LPL | Class II | 2019-01-18 |
| K180229 | RESCAN 700, CALLISTO eye | Carl Zeiss Meditec, AG | OBO | Class II | 2019-01-11 |
| K181444 | CLARUS | Carl Zeiss Meditec, Inc. | QER | Class II | 2019-01-10 |
| K183200 | iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses | C&E GP Specialist, Inc. | MUW | Class II | 2019-01-09 |
| K183175 | BostonSight Scleral | Bostonsight | HQD | Class II | 2019-01-04 |
| K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | HKI | Class II | 2019-01-02 |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | OOE | Class II | 2018-12-21 |
| K183059 | 3nethra neo | Forus Health Pvt.Ltd | HKI | Class II | 2018-12-21 |
| K180820 | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | HKX | Class II | 2018-12-14 |
| K182902 | Precision1 | Alcon Laboratories, Inc. | LPL | Class II | 2018-12-11 |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | CooperVision, Inc. | LPL | Class II | 2018-12-11 |
| K182491 | Applanation tonometer AT-2 | Takagi Seiko Co., Ltd. | HKY | Class II | 2018-12-10 |
| K182506 | LipiScan Dynamic Meibomian Imager | Tearscience, Inc. | HKI | Class II | 2018-12-10 |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | Bausch & Lomb, Incorporated | LPL | Class II | 2018-11-30 |
| K182304 | Hyper GP (tisilfocon A) Daily Wear Contact Lens | Contamac, Ltd. | HQD | Class II | 2018-11-23 |
| K182306 | Sunkingdom Slit Lamp | Chongqing Sunkingdom Medical Instrument Co., Ltd. | HJO | Class II | 2018-11-22 |
| K181454 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal | Alcon Laboratories, Inc. | LPL | Class II | 2018-11-21 |
| K182674 | 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 | Largan Medical Co., Ltd. | LPL | Class II | 2018-11-13 |
| K182083 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | OOE | Class II | 2018-11-09 |
| K182523 | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | LPL | Class II | 2018-11-01 |
| K173944 | Endocular Viewing Lenses and Silicone Ring | Phakos | HJK | Class II | 2018-10-25 |
| K181566 | Nutrifill | Contamac, Ltd. | MRC | Class II | 2018-10-22 |
| K182569 | Spectralis HRA+OCT and variants with High Magnification Module | Heidelberg Engineering GmbH | OBO | Class II | 2018-10-18 |
| K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) | Vizionfocus, Inc. | LPL | Class II | 2018-10-12 |
| K181349 | Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens | Visco Vision, Inc. | LPL | Class II | 2018-09-19 |
| K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module | Heidelberg Engineering GmbH | OBO | Class II | 2018-09-13 |
| K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable | Natus Medical Incorporated | HKI | Class II | 2018-09-07 |
| K181558 | Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens | Gelflex Laboratories | LPL | Class II | 2018-09-06 |
| K173648 | Spectralis HRA + OCT and variants | Heidelberg Engineering GmbH | OBO | Class II | 2018-08-30 |
| K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | HJO | Class II | 2018-08-24 |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | MRC | Class II | 2018-08-10 |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | OOE | Class II | 2018-08-09 |
| K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions | Alcon Laboratories, Inc. | LPL | Class II | 2018-08-03 |
| K173474 | RetiCapture | Ilooda Co,., Ltd. | HKI | Class II | 2018-07-27 |
| K181401 | RxSight Insertion Device | Rxsight, Inc. | MSS | Class I | 2018-07-26 |
| K181579 | eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K | E&E Optics, Inc. | HQD | Class II | 2018-07-26 |
| K180526 | EIDON FA | Centervue S.P.A. | MYC | Class II | 2018-07-16 |
| K181232 | 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 | Largan Medical Co., Ltd. | LPL | Class II | 2018-06-29 |
| K180895 | Alleye | Oculocare Medical AG | HOQ | Class I | 2018-06-27 |
| K181230 | 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 | Largan Medical Co., Ltd. | LPL | Class II | 2018-06-25 |
| K181050 | Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | Qualimed Srl | LPL | Class II | 2018-06-13 |
| K180988 | 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 | Acuity Polymers, Inc. | HQD | Class II | 2018-06-08 |
| K180660 | Avanti | Optovue, Inc. | OBO | Class II | 2018-06-08 |
| K180985 | Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses | Supervision Optimax Sdn Bhd | LPL | Class II | 2018-06-08 |
| K180306 | Nexy | Next Sight Srl | HKI | Class II | 2018-06-08 |
| K180839 | AT 030 | Carl Zeiss Meditec, AG | HKY | Class II | 2018-06-07 |
| K180293 | Retia 2 | Centervue S.P.A. | MYC | Class II | 2018-05-30 |
| K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | Topcon Medical Laser Systems, Inc. | HQF | Class II | 2018-05-25 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.