| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| LPO | Gases Used Within Eye To Place Pressure On Detached Retina | 第 3 类 | 21 CFR 886.4270 | |
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | 第 2 类 | 21 CFR 886.4390 | 13 |
| LRX | Case, Contact Lens | 第 2 类 | 21 CFR 886.5928 | 82 |
| LWL | Fluid, Intraocular | 第 3 类 | 21 CFR 886.4275 | 1 |
| LXP | Plug, Scleral | 第 2 类 | 21 CFR 886.4155 | 10 |
| LXS | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting | 第 2 类 | 21 CFR 886.4392 | 6 |
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | 第 2 类 | 21 CFR 886.5928 | 22 |
| LZP | Aid, Surgical, Viscoelastic | 第 3 类 | 21 CFR 886.4275 | |
| LZR | Ultrasound, Cyclodestructive | 第 2 类 | 21 CFR 886.5350 | |
| MFK | Lens, Multifocal Intraocular | 第 3 类 | 21 CFR 886.3600 | |
| MJP | Lens, Intraocular, Toric Optics | 第 3 类 | 21 CFR 886.3600 | |
| MLP | Keratoprosthesis, Temporary Implant, Surgical Use | 第 2 类 | 21 CFR 886.3400 | 5 |
| MLZ | Vitrectomy, Instrument Cutter | 第 2 类 | 21 CFR 886.4150 | 4 |
| MMC | Dilator, Expansive Iris (Accessory) | 第 2 类 | 21 CFR 886.4150 | |
| MMF | Photorefractor | 第 2 类 | 21 CFR 886.1120 | 1 |
| MML | Weights, Eyelid, External | 第 2 类 | 21 CFR 886.5700 | 14 |
| MMQ | Topographer, Corneal, Ac-Powered | 第 1 类 | 21 CFR 886.1350 | 5 |
| MOE | Collagen Corneal Shield | 第 1 类 | 21 CFR 886.4750 | 19 |
| MQU | Ocular Peg | 第 2 类 | 21 CFR 886.3320 | 4 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 第 2 类 | 21 CFR 886.5918 | 33 |
| MSG | Ophthalmoscopes, Replacement Batteries, Hand-Held | 第 2 类 | 21 CFR 886.1570 | 2 |
| MSR | Tubing, Replacement, Phacofragmentation Unit | 第 2 类 | 21 CFR 886.4150 | 5 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 第 1 类 | 21 CFR 886.4300 | 63 |
| MTZ | Wrap, Implant, Orbital | 第 2 类 | 21 CFR 886.3320 | 2 |
| MUS | Fluidic, Phacoemulsification/Phacofragmentation | 第 2 类 | 21 CFR 886.4670 | 1 |
| MUW | Lens, Contact (Orthokeratology) | 第 2 类 | 21 CFR 886.5916 | 6 |
| MVN | Lens, Contact, (Disposable) | 第 2 类 | 21 CFR 886.5925 | 26 |
| MWL | Lens, Contact (Rigid Gas Permeable), Extended Wear | 第 3 类 | 21 CFR 886.5916 | |
| MXK | Device, Analysis, Anterior Segment | 第 2 类 | 21 CFR 886.1850 | 23 |
| MXO | Laser, System, Phacolysis | 第 2 类 | 21 CFR 886.4670 | |
| MXY | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | 第 1 类 | 21 CFR 886.4350 | |
| MYC | Ophthalmoscope, Laser, Scanning | 第 2 类 | 21 CFR 886.1570 | 22 |
| MYD | Keratome, Water Jet | 第 1 类 | 21 CFR 886.4370 | 1 |
| MZD | System, In-Office Tinting, Contact Lenses | 第 2 类 | 21 CFR 886.5925 | 1 |
| NAA | Lens, Intraocular, Accommodative | 第 3 类 | 21 CFR 886.3600 | |
| NAI | Lens, Prescription, Color Deficiency | 第 1 类 | 21 CFR 886.5844 | 1 |
| NCB | Weights, Eyelid, Implantable | 第 2 类 | 21 CFR 886.5700 | 1 |
| NCE | Injector, Capsular Tension Ring | 第 1 类 | 21 CFR 886.4300 | 3 |
| NCF | Aberrometer, Ophthalmic | 第 1 类 | 21 CFR 886.1760 | 4 |
| NCK | Button, Iris, Eye, Artificial | 第 1 类 | 21 CFR 886.3200 | 1 |
| NCR | Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered | 第 2 类 | 21 CFR 886.4100 | 3 |
| NCZ | Lens, Contact, For Color Vision Deficiency | 第 2 类 | 21 CFR 886.5925 | 1 |
| NFD | Selector, Color, Spectacle, Lens, Tint | 第 1 类 | 21 CFR 886.1160 | 1 |
| NFM | Expander, Tissue, Orbital | 第 2 类 | 21 CFR 886.3320 | 2 |
| NGY | Cannula, Trocar, Ophthalmic | 第 1 类 | 21 CFR 886.4350 | 1 |
| NIC | Lens, Contact, For Reading Discomfort | 第 2 类 | 21 CFR 886.5925 | 1 |
| NIZ | Lens, Iris Reconstruction | 第 3 类 | 21 CFR 886.3600 | |
| NJG | Flasher, Afterimage, Ophthalmic | 第 2 类 | 21 CFR 886.1300 | |
| NJH | Lens, Spectacle (Prescription), For Reading Discomfort | 第 1 类 | 21 CFR 886.5844 | 2 |
| NJJ | Tonometer, Analyzer, Ocular Blood Flow | 第 2 类 | 21 CFR 886.1930 | 1 |
| NKX | Needle, Phacoemulsification, Reprocessed | 第 2 类 | 21 CFR 886.4670 | 5 |
| NKY | Blade, Keratome, Reprocessed | 第 1 类 | 21 CFR 886.4370 | |
| NLA | Knife, Ophthalmic, Reprocessed | 第 1 类 | 21 CFR 886.4350 | |
| NOG | Topographer, Corneal, Battery Powered | 第 1 类 | 21 CFR 886.1350 | |
| NOH | Photokeratoscope, Battery Powered | 第 1 类 | 21 CFR 886.1350 | |
| NOI | Stand, Instrument, Ophthalmic, Battery Powered | 第 1 类 | 21 CFR 886.1860 | |
| NPB | System, Monitoring, For Progress Of Labor | 第 2 类 | 21 CFR 884.2800 | 4 |
| NQB | Conformer, Ophthalmic, Biological Tissue | 第 2 类 | 21 CFR 886.3130 | 1 |
| NQE | Microscope, Specular | 第 2 类 | 21 CFR 886.1850 | 9 |
| NUU | Lens, Contact, Orthokeratology, Overnight | 第 3 类 | 21 CFR 886.5916 | |
| NVB | Intraocular, Pressure Measuring Device | 第 3 类 | 21 CFR 886.4280 | |
| NXM | Prosthesis, Eyelid Spacer/Graft, Biologic | 第 2 类 | 21 CFR 886.3130 | 2 |
| NXR | Fixation, Vision Training, Binocular | 第 1 类 | 21 CFR 886.1290 | 1 |
| NYK | Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate | 第 2 类 | 21 CFR 886.1385 | 1 |
| OBO | Tomography, Optical Coherence | 第 2 类 | 21 CFR 886.1570 | 66 |
| OHW | Burr, Corneal, Battery Powered, Rust Ring Removal | 第 1 类 | 21 CFR 886.4070 | |
| OHX | Burr, Corneal, Ac-Powered, Rust Ring Removal | 第 1 类 | 21 CFR 886.4070 | |
| OJK | Eye Tray | 第 2 类 | 21 CFR 886.4790 | |
| OOE | Ophthalmic Femtosecond Laser | 第 2 类 | 21 CFR 886.4390 | 47 |
| OPT | Infrared Hematoma Detector | 第 2 类 | 21 CFR 882.1935 | 5 |
| ORZ | Eyelid Thermal Pulsation System | 第 2 类 | 21 CFR 886.5200 | 13 |
| OTZ | Graft Insertion Instrument For Endothelial Keratoplasty | 第 1 类 | 21 CFR 886.4300 | 5 |
| OUM | Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimu | 第 1 类 | 21 CFR 886.1050 | 1 |
| PIB | Diabetic Retinopathy Detection Device | 第 2 类 | 21 CFR 886.1100 | 8 |
| PIC | Oral Electronic Vision Aid | 第 2 类 | 21 CFR 886.5905 | 2 |
| PJZ | Camera, Ophthalmic, General-Use | 第 2 类 | 21 CFR 886.1120 | |
| PLX | Tear Duct Occluder | 第 1 类 | 21 CFR 886.5838 | 1 |
| PLZ | Ocular Pattern Recorder | 第 2 类 | 21 CFR 886.1925 | 1 |
| PMW | Strabismus Detection Device | 第 2 类 | 21 CFR 886.1342 | 1 |
| POE | Extended Depth Of Focus Intraocular Lens | 第 3 类 | 21 CFR 886.3600 | |
| PQJ | Intranasal Electrostimulation Device | 第 2 类 | 21 CFR 886.5300 | 1 |
| PUE | Biomicroscope, Slit-Lamp, Ac-Powered, Exempt | 第 2 类 | 21 CFR 886.1850 | |
| PUF | Ocular Peg, Exempt | 第 2 类 | 21 CFR 886.3320 | |
| PUL | Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered | 第 2 类 | 21 CFR 886.4100 | 4 |
| PZG | Surgical Eye Tray | 第 1 类 | 21 CFR 886.4350 | |
| PZK | Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) | 第 3 类 | 21 CFR 886.3600 | |
| QBR | Intranasal Electrostimulation Device For Dry Eye Symptoms | 第 2 类 | 21 CFR 886.5310 | 2 |
| QCB | Phakic Toric Intraocular Lens | 第 3 类 | 21 CFR 886.3600 | |
| QCW | Corneal Storage Media With Preservatives Including Anti-Fungal | 第 2 类 | 21 CFR 886.4320 | 1 |
| QDV | Iol Tray | 第 1 类 | 21 CFR 886.4350 | |
| QDW | Phaco Kit | 第 2 类 | 21 CFR 886.4670 | |
| QDY | Vitrectomy Kit | 第 2 类 | 21 CFR 886.4150 | |
| QER | Camera, Ophthalmic, Slit-Scanning | 第 2 类 | 21 CFR 886.1120 | 3 |
| QGJ | Corneal Inlay Inserter Handle | 第 1 类 | 21 CFR 886.4355 | |
| QIU | Intense Pulsed Light Device For Managing Dry Eye | 第 2 类 | 21 CFR 886.5201 | 1 |
| QKV | Electromechanical Tear Stimulator | 第 2 类 | 21 CFR 886.5305 | 2 |
| QMM | Hydrophilic Re-Coating Solution | 第 2 类 | 21 CFR 886.5919 | 1 |
| QQJ | Applicator, Negative Pressure, External, Ocular | 第 2 类 | 21 CFR 886.5000 | 2 |
| QQQ | Guide And Positioner, Ophthalmic Drug Delivery Device | 第 1 类 | 21 CFR 886.4300 | |
| QQU | Digital Therapy Device For Amblyopia | 第 2 类 | 21 CFR 886.5500 | 5 |
| QTO | Digital Visual Acuity Test | 第 1 类 | 21 CFR 886.1150 | 1 |
| QTW | Digital Amsler Grid | 第 1 类 | 21 CFR 886.1330 | 1 |
| QUR | Prescription Spectacle Lenses To Reduce The Progression Of Myopia | 第 2 类 | 21 CFR 886.5845 | 1 |
| QWU | Prosthesis, Eyelid Spacer/Graft, Polymer | 第 2 类 | 21 CFR 886.3130 | 1 |
| QZP | Camera, Ophthalmic, Non-Prescription | 第 2 类 | 21 CFR 886.1120 | |
| SAX | Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging | 第 2 类 | 21 CFR 886.1600 | 1 |
| SBI | Manual Refractor, 3d Display | 第 1 类 | 21 CFR 886.1770 | 1 |
| SBN | Digital Therapy Device For Convergence Insufficiency | 第 1 类 | 21 CFR 886.1290 | 1 |
| SCW | Digital Prismatic Correction | 第 1 类 | 21 CFR 886.1655 | 2 |
| SDE | Light Based Device For Dry Age-Related Macular Degeneration | 第 2 类 | 21 CFR 886.5520 | 1 |