| Code | Device name | Class | 21 CFR | 510(k) (3y) |
|---|
| FCT | Headlight, Fiberoptic Focusing | Class 2 | 21 CFR 886.4335 | 6 |
| FSR | Light, Headband, Surgical | Class 2 | 21 CFR 886.4335 | 4 |
| FTZ | Locator, Magnetic | Class 1 | 21 CFR 886.4445 | 2 |
| HIT | Tester, Color Vision | Class 1 | 21 CFR 886.1170 | 9 |
| HIW | Anomaloscope | Class 1 | 21 CFR 886.1070 | 3 |
| HIX | Maxwell Spot, Ac-Powered | Class 1 | 21 CFR 886.1435 | 2 |
| HIY | Brush, Haidinger, (Including Macular Integrity) | Class 1 | 21 CFR 886.1090 | |
| HJA | Photokeratoscope | Class 1 | 21 CFR 886.1350 | 5 |
| HJB | Instrument, Measuring, Corneal Radius | Class 1 | 21 CFR 886.1450 | 5 |
| HJC | Esthesiometer, Ocular | Class 1 | 21 CFR 886.1040 | 2 |
| HJD | Illuminator, Color Vision Plate | Class 1 | 21 CFR 886.1160 | 1 |
| HJF | Magnifier, Hand-Held, Low-Vision | Class 1 | 21 CFR 886.5540 | 1 |
| HJG | System, Reading, Television, Closed-Circuit | Class 1 | 21 CFR 886.5820 | 8 |
| HJH | Loupe, Binocular, Low Power | Class 1 | 21 CFR 886.5120 | 3 |
| HJI | Lens, Fundus, Hruby, Diagnostic | Class 1 | 21 CFR 886.1395 | 8 |
| HJJ | Lens, Fresnel, Flexible, Diagnostic | Class 1 | 21 CFR 886.1390 | |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | Class 2 | 21 CFR 886.1385 | 41 |
| HJL | Lens, Condensing, Diagnostic | Class 1 | 21 CFR 886.1380 | 1 |
| HJM | Transilluminator, Ac-Powered | Class 2 | 21 CFR 886.1945 | 12 |
| HJN | Transilluminator, Battery-Powered | Class 1 | 21 CFR 886.1945 | 3 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | Class 2 | 21 CFR 886.1850 | 108 |
| HJQ | Stereoscope, Ac-Powered | Class 1 | 21 CFR 886.1870 | 1 |
| HJR | Stereoscope, Battery-Powered | Class 1 | 21 CFR 886.1870 | |
| HJS | Test, Spectacle Dissociation, Ac-Powered (Lancaster) | Class 1 | 21 CFR 886.1910 | |
| HJT | Haploscope | Class 1 | 21 CFR 886.1340 | 2 |
| HJW | Adaptometer (Biophotometer) | Class 1 | 21 CFR 886.1050 | |
| HJX | Reader, Prism, Ophthalmic | Class 1 | 21 CFR 886.5810 | 1 |
| HJY | Reader, Bar, Ophthalmic | Class 1 | 21 CFR 886.5800 | 1 |
| HJZ | Crutch, Ptosis | Class 1 | 21 CFR 886.5600 | |
| HKB | Telescope, Hand-Held, Low-Vision | Class 1 | 21 CFR 886.5870 | |
| HKC | Spectacle Microscope, Low-Vision | Class 1 | 21 CFR 886.5540 | 1 |
| HKD | Tape, Nystagmus | Class 1 | 21 CFR 886.1905 | |
| HKF | Mirror, Headband, Ophthalmic | Class 1 | 21 CFR 886.1500 | |
| HKG | Fornixscope | Class 1 | 21 CFR 886.1320 | |
| HKI | Camera, Ophthalmic, Ac-Powered | Class 2 | 21 CFR 886.1120 | 157 |
| HKK | Telescope, Spectacle, Low-Vision | Class 1 | 21 CFR 886.5870 | 2 |
| HKL | Retinoscope, Ac-Powered | Class 2 | 21 CFR 886.1780 | 6 |
| HKM | Retinoscope, Battery-Powered | Class 1 | 21 CFR 886.1780 | 7 |
| HKN | Refractor, Manual, Non-Powered, Including Phoropter | Class 1 | 21 CFR 886.1770 | 3 |
| HKO | Refractometer, Ophthalmic | Class 1 | 21 CFR 886.1760 | 35 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | Class 2 | 21 CFR 886.4150 | 16 |
| HKQ | Prism, Rotary, Ophthalmic | Class 1 | 21 CFR 886.1665 | |
| HKR | Lens, Maddox | Class 1 | 21 CFR 886.1400 | |
| HKS | Prism, Gonioscopic | Class 1 | 21 CFR 886.1660 | 10 |
| HKT | Prism, Fresnel, Ophthalmic | Class 1 | 21 CFR 886.1655 | |
| HKW | Prism, Bar, Ophthalmic | Class 1 | 21 CFR 886.1650 | 2 |
| HKX | Tonometer, Ac-Powered | Class 2 | 21 CFR 886.1930 | 58 |
| HKY | Tonometer, Manual | Class 2 | 21 CFR 886.1930 | 56 |
| HKZ | Sterilizer, Tonometer | Class 1 | 21 CFR 886.1940 | |
| HLA | Calibrator, Tonometer | Class 2 | 21 CFR 886.1930 | |
| HLC | Instrument, Measuring, Stereopsis | Class 1 | 21 CFR 886.1460 | |
| HLD | Engine, Trephine, Accessories, Gas-Powered | Class 1 | 21 CFR 886.4070 | |
| HLE | Ruler, Nearpoint (Punctometer) | Class 1 | 21 CFR 886.1790 | |
| HLF | Device, Measuring, Lens Radius, Ophthalmic | Class 1 | 21 CFR 886.1430 | 3 |
| HLG | Pupillometer, Ac-Powered | Class 1 | 21 CFR 886.1700 | 3 |
| HLH | Pupillometer, Manual | Class 1 | 21 CFR 886.1700 | 2 |
| HLI | Ophthalmoscope, Ac-Powered | Class 2 | 21 CFR 886.1570 | 87 |
| HLJ | Ophthalmoscope, Battery-Powered | Class 2 | 21 CFR 886.1570 | 47 |
| HLK | Screen, Tangent, Target, Battery-Powered | Class 1 | 21 CFR 886.1810 | |
| HLL | Monitor, Eye Movement | Class 2 | 21 CFR 886.1510 | 4 |
| HLM | Instrument, Measuring, Lens, Ac-Powered | Class 1 | 21 CFR 886.1425 | 16 |
| HLN | Gauge, Lens, Ophthalmic | Class 1 | 21 CFR 886.1420 | 2 |
| HLO | Test, Spectacle Dissociation, Battery-Powered (Lancaster) | Class 1 | 21 CFR 886.1910 | |
| HLP | Target, Fusion And Stereoscopic | Class 1 | 21 CFR 886.1880 | 3 |
| HLQ | Keratoscope, Ac-Powered | Class 1 | 21 CFR 886.1350 | 29 |
| HLR | Keratoscope, Battery-Powered | Class 1 | 21 CFR 886.1350 | 7 |
| HLS | Exophthalmometer | Class 1 | 21 CFR 886.1270 | 1 |
| HLT | Preamplifier, Ac-Powered, Ophthalmic | Class 2 | 21 CFR 886.1640 | 4 |
| HLW | Preamplifier, Battery-Powered, Ophthalmic | Class 2 | 21 CFR 886.1640 | 3 |
| HLX | Photostimulator, Ac-Powered | Class 2 | 21 CFR 886.1630 | 18 |
| HLZ | Electrode, Corneal | Class 2 | 21 CFR 886.1220 | 11 |
| HMC | Monitor, Eye Movement, Diagnostic | Class 2 | 21 CFR 886.1510 | 1 |
| HMD | Chair, Ophthalmic, Manual | Class 1 | 21 CFR 886.1140 | 1 |
| HME | Chair, Ophthalmic, Ac-Powered | Class 1 | 21 CFR 886.1140 | 16 |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | Class 1 | 21 CFR 886.1860 | 15 |
| HMG | Stand, Instrument, Ophthalmic, Non-Powered | Class 1 | 21 CFR 886.1860 | 4 |
| HMH | Rack, Skiascopic | Class 1 | 21 CFR 886.1750 | 2 |
| HMJ | Screen, Tangent, Projection, Battery-Powered | Class 1 | 21 CFR 886.1810 | 2 |
| HMK | Euthyscope, Ac-Powered | Class 2 | 21 CFR 886.1250 | |
| HML | Euthyscope, Battery-Powered | Class 1 | 21 CFR 886.1250 | |
| HMM | Distometer | Class 1 | 21 CFR 886.1190 | 2 |
| HMQ | Marker, Sclera | Class 1 | 21 CFR 886.4570 | |
| HMR | Marker, Ocular | Class 1 | 21 CFR 886.4570 | 5 |
| HMS | Drum, Eye Knife Test | Class 1 | 21 CFR 886.4230 | 1 |
| HMX | Cannula, Ophthalmic | Class 1 | 21 CFR 886.4350 | 77 |
| HMY | Keratome, Battery-Powered | Class 1 | 21 CFR 886.4370 | 12 |
| HMZ | Trabeculotome | Class 1 | 21 CFR 886.4350 | |
| HNA | Spud, Ophthalmic | Class 1 | 21 CFR 886.4350 | 2 |
| HNB | Spoon, Ophthalmic | Class 1 | 21 CFR 886.4350 | |
| HNC | Specula, Ophthalmic | Class 1 | 21 CFR 886.4350 | 11 |
| HND | Spatula, Ophthalmic | Class 1 | 21 CFR 886.4350 | 6 |
| HNE | Snare, Enucleating | Class 1 | 21 CFR 886.4350 | |
| HNF | Scissors, Ophthalmic | Class 1 | 21 CFR 886.4350 | 15 |
| HNG | Rongeur, Lachrymal Sac | Class 1 | 21 CFR 886.4350 | |
| HNH | Ring, Ophthalmic (Flieringa) | Class 1 | 21 CFR 886.4350 | 7 |
| HNI | Retractor, Ophthalmic | Class 1 | 21 CFR 886.4350 | 2 |
| HNJ | Punch, Corneo-Scleral | Class 1 | 21 CFR 886.4350 | 3 |
| HNK | Probe, Trabeculotomy | Class 1 | 21 CFR 886.4350 | |
| HNL | Probe, Lachrymal | Class 1 | 21 CFR 886.4350 | 10 |
| HNM | Needle, Ophthalmic Suturing | Class 1 | 21 CFR 886.4350 | 2 |
| HNN | Knife, Ophthalmic | Class 1 | 21 CFR 886.4350 | 54 |
| HNO | Keratome, Ac-Powered | Class 1 | 21 CFR 886.4370 | 83 |
| HNP | Introducer, Sphere | Class 1 | 21 CFR 886.4350 | |
| HNQ | Hook, Ophthalmic | Class 1 | 21 CFR 886.4350 | 10 |
| HNR | Forceps, Ophthalmic | Class 1 | 21 CFR 886.4350 | 44 |
| HNS | Expressor | Class 1 | 21 CFR 886.4350 | |
| HNT | Erisophake | Class 1 | 21 CFR 886.4350 | |
| HNW | Dilator, Lachrymal | Class 1 | 21 CFR 886.4350 | 3 |
| HNX | Depressor, Orbital | Class 1 | 21 CFR 886.4350 | 2 |
| HNY | Cystotome | Class 1 | 21 CFR 886.4350 | 20 |
| HNZ | Curette, Ophthalmic | Class 1 | 21 CFR 886.4350 | 2 |
| HOA | Compressor, Orbital | Class 1 | 21 CFR 886.4350 | |
| HOB | Clamp, Muscle, Ophthalmic | Class 1 | 21 CFR 886.4350 | 3 |
| HOC | Clip, Iris Retractor | Class 1 | 21 CFR 886.4350 | 2 |
| HOD | Clamp, Eyelid, Ophthalmic | Class 1 | 21 CFR 886.4350 | 3 |
| HOE | Caliper, Ophthalmic | Class 1 | 21 CFR 886.4350 | 7 |
| HOF | Burr, Corneal, Manual | Class 1 | 21 CFR 886.4350 | 1 |
| HOG | Burr, Corneal, Battery-Powered | Class 1 | 21 CFR 886.4070 | 5 |
| HOH | Spectacle, Operating (Loupe), Ophthalmic | Class 1 | 21 CFR 886.4770 | 3 |
| HOI | Spectacle, Magnifying | Class 1 | 21 CFR 886.5840 | 11 |
| HOJ | Screen, Tangent, Target | Class 1 | 21 CFR 886.1810 | 3 |
| HOK | Screen, Tangent, Projection, Ac-Powered | Class 1 | 21 CFR 886.1810 | 1 |
| HOL | Screen, Tangent, Felt (Campimeter) | Class 1 | 21 CFR 886.1810 | |
| HOM | Screen, Tangent, Ac-Powered (Campimeter) | Class 1 | 21 CFR 886.1810 | 1 |
| HON | Perimeter, Manual | Class 1 | 21 CFR 886.1605 | |
| HOO | Perimeter, Ac-Powered | Class 1 | 21 CFR 886.1605 | 6 |
| HOP | Campimeter, Stereo, Battery-Powered | Class 1 | 21 CFR 886.1810 | |
| HOQ | Grid, Amsler | Class 1 | 21 CFR 886.1330 | 8 |
| HOR | Simulatan (Including Crossed Cylinder) | Class 1 | 21 CFR 886.1840 | 1 |
| HOS | Projector, Ophthalmic | Class 1 | 21 CFR 886.1680 | 9 |
| HOT | Aid, Vision Image Intensification | Class 1 | 21 CFR 886.5910 | 2 |
| HOW | Drum, Opticokinetic | Class 1 | 21 CFR 886.1200 | 1 |
| HOX | Chart, Visual Acuity | Class 1 | 21 CFR 886.1150 | 32 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post | Class 1 | 21 CFR 886.4750 | 55 |
| HOZ | Sponge, Ophthalmic | Class 2 | 21 CFR 886.4790 | 47 |
| HPA | Frame, Trial, Ophthalmic | Class 1 | 21 CFR 886.1415 | 5 |
| HPB | Clip, Lens, Trial, Ophthalmic | Class 1 | 21 CFR 886.1410 | |
| HPC | Set, Lens, Trial, Ophthalmic | Class 1 | 21 CFR 886.1405 | 13 |
| HPD | Lens, Bagolini | Class 1 | 21 CFR 886.1375 | |
| HPE | Aid, Vision, Optical, Battery-Powered | Class 1 | 21 CFR 886.5915 | 1 |
| HPF | Aid, Vision, Electronic, Ac-Powered | Class 1 | 21 CFR 886.5900 | 1 |
| HPG | Aid, Vision, Electronic, Battery-Powered | Class 1 | 21 CFR 886.5900 | 7 |
| HPI | Aid, Vision, Optical, Ac-Powered | Class 1 | 21 CFR 886.5915 | |
| HPJ | Instrument, Visual Field, Laser | Class 2 | 21 CFR 886.1360 | 5 |
| HPK | Tonograph | Class 2 | 21 CFR 886.1930 | |
| HPL | Device, Fixation, Ac-Powered, Ophthalmic | Class 1 | 21 CFR 886.1290 | 7 |
| HPM | Locator, Metal, Electronic | Class 2 | 21 CFR 886.4400 | 4 |
| HPN | Magnet, Permanent | Class 1 | 21 CFR 886.4445 | 5 |
| HPO | Magnet, Ac-Powered | Class 2 | 21 CFR 886.4440 | 3 |
| HPP | Headlamp, Operating, Battery-Operated | Class 1 | 21 CFR 886.4335 | |
| HPQ | Headlamp, Operating, Ac-Powered | Class 2 | 21 CFR 886.4335 | 5 |
| HPS | Unit, Cryophthalmic | Class 2 | 21 CFR 886.4170 | 11 |
| HPT | Perimeter, Automatic, Ac-Powered | Class 1 | 21 CFR 886.1605 | 41 |
| HPW | Probe And Counter, Isotope, For Phosphorus 32 | Class 2 | 21 CFR 886.1670 | |
| HPY | Unit, Electrolysis, Battery-Powered, Ophthalmic | Class 1 | 21 CFR 886.4250 | 1 |
| HPZ | Implant, Eye Sphere | Class 2 | 21 CFR 886.3320 | 39 |
| HQA | Unit, Cryotherapy, Ophthalmic | Class 2 | 21 CFR 886.4170 | 4 |
| HQB | Photocoagulator And Accessories | Class 2 | 21 CFR 886.4690 | 30 |
| HQC | Unit, Phacofragmentation | Class 2 | 21 CFR 886.4670 | 316 |
| HQD | Lens, Contact (Other Material) - Daily | Class 2 | 21 CFR 886.5916 | 118 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Class 2 | 21 CFR 886.4150 | 149 |
| HQF | Laser, Ophthalmic | Class 2 | 21 CFR 886.4390 | 180 |
| HQG | Lens, Spectacle, Non-Custom (Prescription) | Class 1 | 21 CFR 886.5844 | 56 |
| HQH | Eye, Artificial, Non-Custom | Class 1 | 21 CFR 886.3200 | 6 |
| HQJ | Implant, Absorbable, (Scleral Buckling Methods) | Class 2 | 21 CFR 886.3300 | 5 |
| HQL | Intraocular Lens | Class 3 | 21 CFR 886.3600 | 5 |
| HQM | Keratoprosthesis, Permanent Implant | Class 2 | 21 CFR 886.3400 | 4 |
| HQN | Conformer, Ophthalmic | Class 2 | 21 CFR 886.3130 | 7 |
| HQO | Unit, Cautery, Thermal, Ac-Powered | Class 2 | 21 CFR 886.4115 | 12 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | Class 2 | 21 CFR 886.4115 | 24 |
| HQQ | Apparatus, Cautery, Radiofrequency, Battery-Powered | Class 2 | 21 CFR 886.4100 | 3 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | Class 2 | 21 CFR 886.4100 | 11 |
| HQS | Burr, Corneal, Ac-Powered | Class 1 | 21 CFR 886.4070 | 1 |
| HQT | Shell, Scleral | Class 2 | 21 CFR 886.3800 | 4 |
| HQW | Clip, Tantalum, Ophthalmic | Class 2 | 21 CFR 886.3100 | 3 |
| HQX | Implant, Orbital, Extra-Ocular | Class 2 | 21 CFR 886.3340 | 16 |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Class 1 | 21 CFR 886.5850 | 646 |
| HQZ | Frame, Spectacle | Class 1 | 21 CFR 886.5842 | 198 |
| HRC | Sterilizer, Soft-Lens, Thermal, Battery-Powered | Class 2 | 21 CFR 886.5928 | 1 |
| HRD | Sterilizer, Soft-Lens, Thermal, Ac-Powered | Class 2 | 21 CFR 886.5928 | 1 |
| HRE | Cabinet, Instrument, Ac-Powered, Ophthalmic | Class 1 | 21 CFR 886.1860 | |
| HRF | Engine, Trephine, Accessories, Battery-Powered | Class 1 | 21 CFR 886.4070 | |
| HRG | Engine, Trephine, Accessories, Ac-Powered | Class 1 | 21 CFR 886.4070 | 6 |
| HRH | Trephine, Manual, Ophthalmic | Class 1 | 21 CFR 886.4350 | 12 |
| HRI | Pupillograph | Class 1 | 21 CFR 886.1690 | |
| HRJ | Table, Instrument, Powered, Ophthalmic | Class 1 | 21 CFR 886.4855 | 7 |
| HRK | Table, Instrument, Manual, Ophthalmic | Class 1 | 21 CFR 886.4855 | 2 |
| HRL | Unit, Beta, Radiation, Ophthalmic | Class 2 | 21 CFR 886.5100 | |
| HRN | Unit, Cryophthalmic, Ac-Powered | Class 2 | 21 CFR 886.4170 | 10 |
| HRO | Unit, Electrolysis, Ac-Powered, Ophthalmic | Class 2 | 21 CFR 886.4250 | |
| HRP | Pen, Marking, Surgical | Class 1 | 21 CFR 886.4570 | |
| KYB | Lens, Guide, Intraocular | Class 1 | 21 CFR 886.4300 | 39 |
| KYD | Strip, Schirmer | Class 1 | 21 CFR 886.1800 | 3 |
| KYE | Inserter/Remover Contact Lens | Class 1 | 21 CFR 886.5420 | 12 |
| KYF | Implant, Eye Valve | Class 2 | 21 CFR 886.3920 | 25 |
| KYG | Device, Irrigation, Ocular Surgery | Class 1 | 21 CFR 886.4360 | 40 |
| LCC | Applicator, Ocular Pressure | Class 2 | 21 CFR 886.4610 | 6 |
| LPL | Lenses, Soft Contact, Daily Wear | Class 2 | 21 CFR 886.5925 | 486 |
| LPM | Lenses, Soft Contact, Extended Wear | Class 3 | 21 CFR 886.5925 | |
| LPN | Accessories, Soft Lens Products | Class 2 | 21 CFR 886.5928 | 121 |