Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 30
- Latest Decision
- 2024-06-21
Clearances · page 2 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | HQC | Class II | 2024-06-21 |
| K232930 | VERVE | Oculomotor Technologies | SBN | Class I | 2024-06-13 |
| K233295 | LFR-260 | Evolution Optiks Limited | SBI | Class I | 2024-05-31 |
| K233933 | CIRRUS HD-OCT Model 6000 | Carl Zeiss Meditec, Inc. | OBO | Class II | 2024-05-17 |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. | HKI | Class II | 2024-05-15 |
| DEN230043 | Notal Vision Home Optical Coherence Tomography (OCT) System | Notal Vision, Inc. | SAX | Class II | 2024-05-15 |
| K233602 | P200TE (A10700) | Optos Plc. | OBO | Class II | 2024-05-09 |
| K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | LPL | Class II | 2024-05-08 |
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | Reichert, Inc. | HKY | Class II | 2024-05-01 |
| K240058 | AEYE-DS | Aeye Health, Inc. | PIB | Class II | 2024-04-23 |
| K240519 | Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens | Innova Vision, Inc. | LPL | Class II | 2024-04-17 |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | OBO | Class II | 2024-04-10 |
| K240618 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | HQD | Class II | 2024-04-03 |
| K231760 | HP-OCT (HP-OCT) | Cylite Pty. , Ltd. | HJO | Class II | 2024-03-08 |
| K233421 | RESCAN 700 | Carl Zeiss Meditec, AG | OBO | Class II | 2024-03-08 |
| K232084 | Stellaris Elite vision enhancement system | Bausch and Lomb | HQC | Class II | 2024-02-26 |
| K233325 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) | Visionary Optics, LLC | HQD | Class II | 2024-02-21 |
| K234037 | CATS-L Tonometer Prism | Cats Tonometer, LLC | HKY | Class II | 2024-02-09 |
| K233221 | Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | Metro Optics of Austin, Inc. | LPL | Class II | 2024-02-06 |
| K232417 | MR Q; MR Q SUPINE; MR Q SLT | Meridian AG | HQF | Class II | 2024-01-25 |
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | CooperVision, Inc. | LPL | Class II | 2024-01-25 |
| K233902 | Centurion Vision System (Active Sentry) (8065753057) | Alcon Laboratories, Inc. | HQC | Class II | 2024-01-10 |
| K223397 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | Hoya Lamphun , Ltd. | LPL | Class II | 2024-01-03 |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal | Alcon Laboratories, Inc. | LPL | Class II | 2023-12-29 |
| K231084 | TearCare MGX System | Sight Sciences, Inc. | ORZ | Class II | 2023-12-27 |
| K223585 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear | Yung Sheng Optical Co., Ltd. | LPL | Class II | 2023-12-20 |
| K230722 | Eagle device | Belkin Vision, Ltd. | HQF | Class II | 2023-12-08 |
| K232273 | RM Electrode (RMH 23-01) | Retmap, Inc. | HLZ | Class II | 2023-12-07 |
| K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | HKI | Class II | 2023-12-05 |
| K230627 | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | HKI | Class II | 2023-11-20 |
| K230954 | Samfilcon B Custom Contact Lens | Bausch + Lomb, Incorporated | LPL | Class II | 2023-11-17 |
| K232139 | Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Innova Vision, Inc. | LPL | Class II | 2023-11-16 |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric | Alcon Laboratories, Inc. | LPL | Class II | 2023-11-16 |
| K223739 | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | HKX | Class II | 2023-11-08 |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | OBO | Class II | 2023-10-30 |
| K232051 | VISULAS green | Carl Zeiss Meditec | HQF | Class II | 2023-10-24 |
| K232143 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | HKY | Class II | 2023-10-23 |
| K223557 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | OBO | Class II | 2023-10-20 |
| K230897 | Anterion | Heidelberg Engineering GmbH | OBO | Class II | 2023-10-11 |
| K230350 | VISULAS yag | Carl Zeiss Meditec, Inc. | HQF | Class II | 2023-09-22 |
| K231106 | Accuject Refra Injector AR2900 | Medicel AG | MSS | Class I | 2023-09-19 |
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | Meridian AG | HQF | Class II | 2023-09-12 |
| K223575 | Phoenix ICON, Phoenix ICON GO | Neolight, LLC | HKI | Class II | 2023-09-06 |
| K230824 | IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | Art Optical Contact Lens, Inc. | LPL | Class II | 2023-09-06 |
| K221601 | MS-39 | C.S.O. S.R.L. | OBO | Class II | 2023-09-01 |
| K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) | Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. | LRX | Class II | 2023-08-30 |
| K231673 | P200TE (A10700) | Optos Plc. | OBO | Class II | 2023-08-18 |
| K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | MSS | Class I | 2023-08-15 |
| K230858 | QUATERA 700 | Carl Zeiss Meditec, AG | HQC | Class II | 2023-07-31 |
| K222933 | MYAH | Visia Imaging S.R.L. | MXK | Class II | 2023-06-29 |
| K223357 | EyeArt v2.2.0 | Eyenuk, Inc. | PIB | Class II | 2023-06-16 |
| K230965 | Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | HQD | Class II | 2023-06-16 |
| K230910 | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens | Acculens, Inc. | HQD | Class II | 2023-06-16 |
| K231466 | RxSight Insertion Device | Rxsight, Inc. | MSS | Class I | 2023-06-12 |
| K223074 | CorNeat EverPatch | Corneat Vision , Ltd. | QWU | Class II | 2023-06-02 |
| K222885 | Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | Pegavision Corporation | LPL | Class II | 2023-05-31 |
| K231051 | Ahmed® Glaucoma Valve Model FP8 | New World Medical, Inc. | KYF | Class II | 2023-05-12 |
| K230975 | Ahmed® Glaucoma Valve Model FP7 | New World Medical, Inc. | KYF | Class II | 2023-05-12 |
| K222484 | Retitrack | C. Light Technologies, Inc. | HLL | Class II | 2023-05-09 |
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | Paragon Vision Sciences, Inc. | HQD | Class II | 2023-05-05 |
| K230785 | Precision1, Precision1 for Astigmatism | Alcon Laboratories, Inc. | LPL | Class II | 2023-04-20 |
| K223566 | ELITA Femtosecond Laser System, ELITA Patient Interface | Johnson & Johnson Surgical Vision, Inc. | OOE | Class II | 2023-04-14 |
| K222200 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | OBO | Class II | 2023-04-13 |
| K223838 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | OOE | Class II | 2023-04-12 |
| K223763 | ZeptoLink IOL Positioning System | Centricity Vision, Inc. | PUL | Class II | 2023-04-11 |
| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX | Nidek Co., Ltd. | OBO | Class II | 2023-03-30 |
| K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | HKI | Class II | 2023-03-15 |
| K222954 | Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens | Innova Vision, Inc. | LPL | Class II | 2023-03-13 |
| K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | Bausch & Lomb, Incorporated | LPL | Class II | 2023-03-08 |
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | Iridex Corporation | HQF | Class II | 2023-02-23 |
| K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | HKI | Class II | 2023-02-22 |
| K220974 | R:GEN | Lutronic Vision, Inc. | HQF | Class II | 2022-12-27 |
| K223394 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) | Visionary Optics, LLC | HQD | Class II | 2022-12-07 |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | Bausch & Lomb, Incorporated | LPN | Class II | 2022-12-06 |
| K222372 | Kowa SL-19 | Kowa Company , Ltd. | HJO | Class II | 2022-11-21 |
| K221183 | AEYE-DS | Aeye Health, Inc. | PIB | Class II | 2022-11-10 |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Iridex Corporation | HQF | Class II | 2022-11-09 |
| K222166 | SOLIX | Optovue, Inc. | OBO | Class II | 2022-11-09 |
| K221659 | Luminopia One | Luminopia, Inc. | QQU | Class II | 2022-11-04 |
| K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers | Vortex Surgical, Inc. | HQB | Class II | 2022-11-03 |
| K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | Ellex Medical Pty, Ltd. | HQF | Class II | 2022-11-02 |
| K221263 | Aqua Naina Plus Sterile Saline Solution | Chemtex USA, Inc. | LPN | Class II | 2022-10-12 |
| K222157 | ECHO Photocoagulator | Norlase | HQF | Class II | 2022-10-11 |
| K220852 | iCare IC200 | Icare Finland OY | HKY | Class II | 2022-10-06 |
| K221517 | POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens | INTEROJO, Inc. | LPL | Class II | 2022-10-04 |
| K221375 | CureSight-CS100 | Novasight , Ltd. | QQU | Class II | 2022-09-29 |
| K222500 | AIR OPTIX COLORS | Alcon Laboratories, Inc. | LPL | Class II | 2022-09-15 |
| K214028 | MICOR Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | HQC | Class II | 2022-09-09 |
| K220143 | BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | Shenzhen Dashicheng Optical Technology Co., Ltd. | LPL | Class II | 2022-09-08 |
| K203594 | EyeCTester | Neuro-Eye Diagnostic Systems, LLC | QTW | Class I | 2022-09-07 |
| K213983 | Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear | Yung Sheng Optical Co., Ltd. | LPL | Class II | 2022-09-02 |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Topcon Corporation | HKI | Class II | 2022-08-29 |
| K222236 | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | HQC | Class II | 2022-08-24 |
| K220090 | Visibly Digital Acuity Product | Visibly, Inc. | QTO | Class I | 2022-08-12 |
| K212763 | UniVit HE, UniVit UHS | Visioncare Devices, LLC | HQE | Class II | 2022-08-10 |
| K220045 | TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | Dk Medivision Co., Ltd. | LPL | Class II | 2022-08-05 |
| K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | Glaukos Corporation | KYF | Class II | 2022-08-02 |
| K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | Lumenis Be, Inc. | HQF | Class II | 2022-07-15 |
| K212741 | EZYPOR | Fci (France Chirurgie Instrumentation) Sas | HPZ | Class II | 2022-06-24 |
| K221188 | ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. | PUL | Class II | 2022-06-23 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.