Part 886 Subpart B—Diagnostic Devices
FDA submissions for Part 886 Subpart B—Diagnostic Devices in the Ophthalmic (OP) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 886.1040–886.1945
CFR Part: 886
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| HJC | Esthesiometer, Ocular | 886.1040 | 1 | 2 |
| HJW | Adaptometer (Biophotometer) | 886.1050 | 1 | 0 |
| OUM | Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation | 886.1050 | 1 | 1 |
| HIW | Anomaloscope | 886.1070 | 1 | 3 |
| HIY | Brush, Haidinger, (Including Macular Integrity) | 886.1090 | 1 | 0 |
| PIB | Diabetic Retinopathy Detection Device | 886.1100 | 2 | 7 |
| HKI | Camera, Ophthalmic, Ac-Powered | 886.1120 | 2 | 156 |
| MMF | Photorefractor | 886.1120 | 2 | 1 |
| PJZ | Camera, Ophthalmic, General-Use | 886.1120 | 2 | 0 |
| QER | Camera, Ophthalmic, Slit-Scanning | 886.1120 | 2 | 3 |
| QZP | Camera, Ophthalmic, Non-Prescription | 886.1120 | 2 | 0 |
| HMD | Chair, Ophthalmic, Manual | 886.1140 | 1 | 1 |
| HME | Chair, Ophthalmic, Ac-Powered | 886.1140 | 1 | 16 |
| HOX | Chart, Visual Acuity | 886.1150 | 1 | 32 |
| QTO | Digital Visual Acuity Test | 886.1150 | 1 | 1 |
| HJD | Illuminator, Color Vision Plate | 886.1160 | 1 | 1 |
| NFD | Selector, Color, Spectacle, Lens, Tint | 886.1160 | 1 | 1 |
| HIT | Tester, Color Vision | 886.1170 | 1 | 9 |
| HMM | Distometer | 886.1190 | 1 | 2 |
| HOW | Drum, Opticokinetic | 886.1200 | 1 | 1 |
| HLZ | Electrode, Corneal | 886.1220 | 2 | 11 |
| HMK | Euthyscope, Ac-Powered | 886.1250 | 2 | 0 |
| HML | Euthyscope, Battery-Powered | 886.1250 | 1 | 0 |
| HLS | Exophthalmometer | 886.1270 | 1 | 1 |
| HPL | Device, Fixation, Ac-Powered, Ophthalmic | 886.1290 | 1 | 7 |
| NXR | Fixation, Vision Training, Binocular | 886.1290 | 1 | 1 |
| SBN | Digital Therapy Device For Convergence Insufficiency | 886.1290 | 1 | 1 |
| NJG | Flasher, Afterimage, Ophthalmic | 886.1300 | 2 | 0 |
| HKG | Fornixscope | 886.1320 | 1 | 0 |
| HOQ | Grid, Amsler | 886.1330 | 1 | 8 |
| QTW | Digital Amsler Grid | 886.1330 | 1 | 1 |
| HJT | Haploscope | 886.1340 | 1 | 2 |
| PMW | Strabismus Detection Device | 886.1342 | 2 | 1 |
| HJA | Photokeratoscope | 886.1350 | 1 | 5 |
| HLQ | Keratoscope, Ac-Powered | 886.1350 | 1 | 29 |
| HLR | Keratoscope, Battery-Powered | 886.1350 | 1 | 7 |
| MMQ | Topographer, Corneal, Ac-Powered | 886.1350 | 1 | 5 |
| NOG | Topographer, Corneal, Battery Powered | 886.1350 | 1 | 0 |
| NOH | Photokeratoscope, Battery Powered | 886.1350 | 1 | 0 |
| HPJ | Instrument, Visual Field, Laser | 886.1360 | 2 | 5 |
| HPD | Lens, Bagolini | 886.1375 | 1 | 0 |
| HJL | Lens, Condensing, Diagnostic | 886.1380 | 1 | 1 |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 886.1385 | 2 | 41 |
| NYK | Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma) | 886.1385 | 2 | 1 |
| HJJ | Lens, Fresnel, Flexible, Diagnostic | 886.1390 | 1 | 0 |
| HJI | Lens, Fundus, Hruby, Diagnostic | 886.1395 | 1 | 8 |
| HKR | Lens, Maddox | 886.1400 | 1 | 0 |
| HPC | Set, Lens, Trial, Ophthalmic | 886.1405 | 1 | 13 |
| HPB | Clip, Lens, Trial, Ophthalmic | 886.1410 | 1 | 0 |
| HPA | Frame, Trial, Ophthalmic | 886.1415 | 1 | 5 |
| HLN | Gauge, Lens, Ophthalmic | 886.1420 | 1 | 2 |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 886.1425 | 1 | 16 |
| HLF | Device, Measuring, Lens Radius, Ophthalmic | 886.1430 | 1 | 3 |
| HIX | Maxwell Spot, Ac-Powered | 886.1435 | 1 | 2 |
| HJB | Instrument, Measuring, Corneal Radius | 886.1450 | 1 | 5 |
| HLC | Instrument, Measuring, Stereopsis | 886.1460 | 1 | 0 |
| HKF | Mirror, Headband, Ophthalmic | 886.1500 | 1 | 0 |
| HLL | Monitor, Eye Movement | 886.1510 | 2 | 4 |
| HMC | Monitor, Eye Movement, Diagnostic | 886.1510 | 2 | 1 |
| HLI | Ophthalmoscope, Ac-Powered | 886.1570 | 2 | 87 |
| HLJ | Ophthalmoscope, Battery-Powered | 886.1570 | 2 | 47 |
| MSG | Ophthalmoscopes, Replacement Batteries, Hand-Held | 886.1570 | 2 | 2 |
| MYC | Ophthalmoscope, Laser, Scanning | 886.1570 | 2 | 22 |
| OBO | Tomography, Optical Coherence | 886.1570 | 2 | 65 |
| SAX | Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device | 886.1600 | 2 | 1 |
| HON | Perimeter, Manual | 886.1605 | 1 | 0 |
| HOO | Perimeter, Ac-Powered | 886.1605 | 1 | 6 |
| HPT | Perimeter, Automatic, Ac-Powered | 886.1605 | 1 | 41 |
| HLX | Photostimulator, Ac-Powered | 886.1630 | 2 | 18 |
| HLT | Preamplifier, Ac-Powered, Ophthalmic | 886.1640 | 2 | 4 |
| HLW | Preamplifier, Battery-Powered, Ophthalmic | 886.1640 | 2 | 3 |
| HKW | Prism, Bar, Ophthalmic | 886.1650 | 1 | 2 |
| HKT | Prism, Fresnel, Ophthalmic | 886.1655 | 1 | 0 |
| SCW | Digital Prismatic Correction | 886.1655 | 1 | 2 |
| HKS | Prism, Gonioscopic | 886.1660 | 1 | 10 |
| HKQ | Prism, Rotary, Ophthalmic | 886.1665 | 1 | 0 |
| HPW | Probe And Counter, Isotope, For Phosphorus 32 | 886.1670 | 2 | 0 |
| HOS | Projector, Ophthalmic | 886.1680 | 1 | 9 |
| HRI | Pupillograph | 886.1690 | 1 | 0 |
| HLG | Pupillometer, Ac-Powered | 886.1700 | 1 | 3 |
| HLH | Pupillometer, Manual | 886.1700 | 1 | 2 |
| HMH | Rack, Skiascopic | 886.1750 | 1 | 2 |
| HKO | Refractometer, Ophthalmic | 886.1760 | 1 | 35 |
| NCF | Aberrometer, Ophthalmic | 886.1760 | 1 | 4 |
| HKN | Refractor, Manual, Non-Powered, Including Phoropter | 886.1770 | 1 | 3 |
| SBI | Manual Refractor, 3d Display | 886.1770 | 1 | 1 |
| HKL | Retinoscope, Ac-Powered | 886.1780 | 2 | 6 |
| HKM | Retinoscope, Battery-Powered | 886.1780 | 1 | 7 |
| HLE | Ruler, Nearpoint (Punctometer) | 886.1790 | 1 | 0 |
| KYD | Strip, Schirmer | 886.1800 | 1 | 3 |
| HLK | Screen, Tangent, Target, Battery-Powered | 886.1810 | 1 | 0 |
| HMJ | Screen, Tangent, Projection, Battery-Powered | 886.1810 | 1 | 2 |
| HOJ | Screen, Tangent, Target | 886.1810 | 1 | 3 |
| HOK | Screen, Tangent, Projection, Ac-Powered | 886.1810 | 1 | 1 |
| HOL | Screen, Tangent, Felt (Campimeter) | 886.1810 | 1 | 0 |
| HOM | Screen, Tangent, Ac-Powered (Campimeter) | 886.1810 | 1 | 1 |
| HOP | Campimeter, Stereo, Battery-Powered | 886.1810 | 1 | 0 |
| HOR | Simulatan (Including Crossed Cylinder) | 886.1840 | 1 | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 886.1850 | 2 | 108 |
| MXK | Device, Analysis, Anterior Segment | 886.1850 | 2 | 23 |
| NQE | Microscope, Specular | 886.1850 | 2 | 9 |
| PUE | Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | 886.1850 | 2 | 0 |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | 886.1860 | 1 | 15 |
| HMG | Stand, Instrument, Ophthalmic, Non-Powered | 886.1860 | 1 | 4 |
| HRE | Cabinet, Instrument, Ac-Powered, Ophthalmic | 886.1860 | 1 | 0 |
| NOI | Stand, Instrument, Ophthalmic, Battery Powered | 886.1860 | 1 | 0 |
| HJQ | Stereoscope, Ac-Powered | 886.1870 | 1 | 1 |
| HJR | Stereoscope, Battery-Powered | 886.1870 | 1 | 0 |
| HLP | Target, Fusion And Stereoscopic | 886.1880 | 1 | 3 |
| HKD | Tape, Nystagmus | 886.1905 | 1 | 0 |
| HJS | Test, Spectacle Dissociation, Ac-Powered (Lancaster) | 886.1910 | 1 | 0 |
| HLO | Test, Spectacle Dissociation, Battery-Powered (Lancaster) | 886.1910 | 1 | 0 |
| PLZ | Ocular Pattern Recorder | 886.1925 | 2 | 1 |
| HKX | Tonometer, Ac-Powered | 886.1930 | 2 | 58 |
| HKY | Tonometer, Manual | 886.1930 | 2 | 56 |
| HLA | Calibrator, Tonometer | 886.1930 | 2 | 0 |
| HPK | Tonograph | 886.1930 | 2 | 0 |
| NJJ | Tonometer, Analyzer, Ocular Blood Flow | 886.1930 | 2 | 1 |
| HKZ | Sterilizer, Tonometer | 886.1940 | 1 | 0 |
| HJM | Transilluminator, Ac-Powered | 886.1945 | 2 | 12 |
| HJN | Transilluminator, Battery-Powered | 886.1945 | 1 | 3 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K253586 | RM Electrode (RMH 25-01) | Retmap, Inc. | Apr 1, 2026 |
| K253834 | VISUREF 600 | Carl Zeiss Vision GmbH | Mar 18, 2026 |
| K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | Mar 13, 2026 |
| K251353 | Eyer 2 | Phelcom Technologies | Jan 16, 2026 |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | Dec 23, 2025 |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | Dec 18, 2025 |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | Dec 12, 2025 |
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | Nov 7, 2025 |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | Sep 4, 2025 |
| K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | Aug 14, 2025 |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | Jul 18, 2025 |
| K250143 | Digital Prism Correction Feature (DPCF) | Apple, Inc. | Jun 23, 2025 |
| K250868 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | May 12, 2025 |
| K250683 | Resolve Fundus Camera | Optain Health, Inc. | Apr 30, 2025 |
| K241931 | OcuMet Beacon (OCUB100) | Ocusciences, Inc. | Apr 22, 2025 |
| K243878 | CLARUS (700) | Carl Zeiss Meditec, Inc. | Apr 17, 2025 |
| K243504 | MAIA (AHMACME001) | Centervue S.P.A. | Mar 17, 2025 |
| K243664 | Sentinel Camera | Ai Optics | Dec 17, 2024 |
| K240924 | Anterion | Heidelberg Engineering GmbH | Dec 13, 2024 |
| K242508 | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | Dec 9, 2024 |
| K242058 | Digital Prism Correction Feature (DPCF) | Apple, Inc. | Oct 21, 2024 |
| K241163 | SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | Oct 11, 2024 |
| K241447 | iCare ST500 (TA04) | Icare Finland OY | Sep 27, 2024 |
| K223700 | BOSS | Intelon Optics, Inc. | Aug 16, 2024 |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Topcon Corporation | Jul 17, 2024 |
| K240221 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | Jul 1, 2024 |
| K232930 | VERVE | Oculomotor Technologies | Jun 13, 2024 |
| K233295 | LFR-260 | Evolution Optiks Limited | May 31, 2024 |
| K233933 | CIRRUS HD-OCT Model 6000 | Carl Zeiss Meditec, Inc. | May 17, 2024 |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. | May 15, 2024 |
| DEN230043 | Notal Vision Home Optical Coherence Tomography (OCT) System | Notal Vision, Inc. | May 15, 2024 |
| K233602 | P200TE (A10700) | Optos Plc. | May 9, 2024 |
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | Reichert, Inc. | May 1, 2024 |
| K240058 | AEYE-DS | Aeye Health, Inc. | Apr 23, 2024 |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | Apr 10, 2024 |
| K233421 | RESCAN 700 | Carl Zeiss Meditec, AG | Mar 8, 2024 |
| K231760 | HP-OCT (HP-OCT) | Cylite Pty. , Ltd. | Mar 8, 2024 |
| K234037 | CATS-L Tonometer Prism | Cats Tonometer, LLC | Feb 9, 2024 |
| K232273 | RM Electrode (RMH 23-01) | Retmap, Inc. | Dec 7, 2023 |
| K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | Dec 5, 2023 |
| K230627 | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | Nov 20, 2023 |
| K223739 | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | Nov 8, 2023 |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | Oct 30, 2023 |
| K232143 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | Oct 23, 2023 |
| K223557 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | Oct 20, 2023 |
| K230897 | Anterion | Heidelberg Engineering GmbH | Oct 11, 2023 |
| K223575 | Phoenix ICON, Phoenix ICON GO | Neolight, LLC | Sep 6, 2023 |
| K221601 | MS-39 | C.S.O. S.R.L. | Sep 1, 2023 |
| K231673 | P200TE (A10700) | Optos Plc. | Aug 18, 2023 |
| K222933 | MYAH | Visia Imaging S.R.L. | Jun 29, 2023 |
| K223357 | EyeArt v2.2.0 | Eyenuk, Inc. | Jun 16, 2023 |
| K222484 | Retitrack | C. Light Technologies, Inc. | May 9, 2023 |
| K222200 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | Apr 13, 2023 |
| 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. | Mar 30, 2023 |
| K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | Mar 15, 2023 |
| K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | Feb 22, 2023 |
| K222372 | Kowa SL-19 | Kowa Company , Ltd. | Nov 21, 2022 |
| K221183 | AEYE-DS | Aeye Health, Inc. | Nov 10, 2022 |
| K222166 | SOLIX | Optovue, Inc. | Nov 9, 2022 |
| K220852 | iCare IC200 | Icare Finland OY | Oct 6, 2022 |
| K203594 | EyeCTester | Neuro-Eye Diagnostic Systems, LLC | Sep 7, 2022 |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Topcon Corporation | Aug 29, 2022 |
| K220090 | Visibly Digital Acuity Product | Visibly, Inc. | Aug 12, 2022 |
| K213037 | IDx-DR v2.3 | Digital Diagnostics, Inc. | Jun 17, 2022 |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | Apr 27, 2022 |
| K211868 | MYAH | Visia Imaging S.R.L. | Mar 1, 2022 |
| K211355 | iCare HOME2 | Icare Finland OY | Jan 25, 2022 |
| K213705 | DRSplus | Centervue S.P.A. | Dec 21, 2021 |
| K211817 | Anterion | Heidelberg Engineering GmbH | Nov 5, 2021 |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Centervue S.P.A. | Aug 19, 2021 |
| K202989 | Myopia Master | Oculus Optikgeräte GmbH | Jul 14, 2021 |
| K203850 | CATS®-D Tonometer Prism | Cats Tonometer, LLC | Jun 14, 2021 |
| K203629 | IDx-DR | Digital Diagnostics, Inc. | Jun 10, 2021 |
| K210197 | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | Apr 13, 2021 |
| K203500 | RetCam Envision | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Apr 13, 2021 |
| K202097 | Fundus Camera | Huvitz Co., Ltd. | Feb 2, 2021 |
| K202221 | VX650 | Luneau Technology Operations | Jan 29, 2021 |
| K201325 | Optomed Smartscope M5 with Optomed Smartscope FA | Optomed Oyj | Nov 20, 2020 |
| K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | Oct 21, 2020 |
| K201909 | RxSight Contact Lens | Rxsight, Inc. | Sep 10, 2020 |
| K201252 | Spectralis HRA+OCT and variants | Heidelberg Engineering GmbH | Sep 9, 2020 |
| K200516 | OCT-Camera ID 21101A3 | Optomedical Technologies GmbH | Sep 2, 2020 |
| K200667 | EyeArt | Eyenuk, Inc. | Aug 3, 2020 |
| K201122 | Canon non-mydriatic retinal camera CR series | Canon, Inc. | Jul 23, 2020 |
| K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | Vasoptic Medical, Inc. | Jun 1, 2020 |
| K200966 | Icare HOME Tonometer | Icare Finland OY | May 7, 2020 |
| K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Optina Diagnostics | Apr 27, 2020 |
| K191558 | Konan Specular Microscope XVII | Konan Medical, Inc. | Mar 26, 2020 |
| K190954 | Fundus Camera | Chongqing Bio Newvision Medical Equipment , Ltd. | Jan 22, 2020 |
| K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | Jan 14, 2020 |
| K190316 | Icare ic200 | Icare Finland OY | Jan 14, 2020 |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co., Ltd. | Dec 19, 2019 |
| K190382 | Intraocular Pressure Tonometer EASYTON | Company Elamed | Dec 6, 2019 |
| K192113 | DRSplus | Centervue S.P.A. | Nov 15, 2019 |
| K192391 | Spectralis HRA+OCT and Variants | Heidelberg Engineering GmbH | Sep 26, 2019 |
| K191945 | KOWA nonmyd 8 | Kowa Company , Ltd. | Sep 10, 2019 |
| K190732 | P200TxE | Optos Plc. | Jul 31, 2019 |
| K182659 | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | Jul 25, 2019 |
| K182942 | Canon OCT-A1 | Canon, Inc. | Jul 24, 2019 |
| K191194 | CLARUS | Carl Zeiss Meditec, Inc. | Jun 25, 2019 |
