Part 886 Subpart F—Therapeutic Devices
FDA submissions for Part 886 Subpart F—Therapeutic Devices in the Ophthalmic (OP) review panel, including product codes and regulations.
Section range: §§ 886.5000–886.5928
CFR Part: 886
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| QQJ | Applicator, Negative Pressure, External, Ocular | 886.5000 | 2 | 1 |
| HRL | Unit, Beta, Radiation, Ophthalmic | 886.5100 | 2 | 0 |
| HJH | Loupe, Binocular, Low Power | 886.5120 | 1 | 3 |
| ORZ | Eyelid Thermal Pulsation System | 886.5200 | 2 | 11 |
| QIU | Intense Pulsed Light Device For Managing Dry Eye | 886.5201 | 2 | 1 |
| PQJ | Intranasal Electrostimulation Device | 886.5300 | 2 | 1 |
| QKV | Electromechanical Tear Stimulator | 886.5305 | 2 | 2 |
| QBR | Intranasal Electrostimulation Device For Dry Eye Symptoms | 886.5310 | 2 | 2 |
| LZR | Ultrasound, Cyclodestructive | 886.5350 | 2 | 1 |
| KYE | Inserter/Remover Contact Lens | 886.5420 | 1 | 12 |
| QQU | Digital Therapy Device For Amblyopia | 886.5500 | 2 | 5 |
| SDE | Light Based Device For Dry Age-Related Macular Degeneration | 886.5520 | 2 | 1 |
| HJF | Magnifier, Hand-Held, Low-Vision | 886.5540 | 1 | 1 |
| HKC | Spectacle Microscope, Low-Vision | 886.5540 | 1 | 1 |
| HJZ | Crutch, Ptosis | 886.5600 | 1 | 0 |
| MML | Weights, Eyelid, External | 886.5700 | 2 | 14 |
| NCB | Weights, Eyelid, Implantable | 886.5700 | 2 | 1 |
| HJY | Reader, Bar, Ophthalmic | 886.5800 | 1 | 1 |
| HJX | Reader, Prism, Ophthalmic | 886.5810 | 1 | 1 |
| HJG | System, Reading, Television, Closed-Circuit | 886.5820 | 1 | 8 |
| PLX | Tear Duct Occluder | 886.5838 | 1 | 1 |
| HOI | Spectacle, Magnifying | 886.5840 | 1 | 11 |
| HQZ | Frame, Spectacle | 886.5842 | 1 | 198 |
| HQG | Lens, Spectacle, Non-Custom (Prescription) | 886.5844 | 1 | 56 |
| NAI | Lens, Prescription, Color Deficiency | 886.5844 | 1 | 1 |
| NJH | Lens, Spectacle (Prescription), For Reading Discomfort | 886.5844 | 1 | 2 |
| QUR | Prescription Spectacle Lenses To Reduce The Progression Of Myopia | 886.5845 | 2 | 1 |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 886.5850 | 1 | 646 |
| HKB | Telescope, Hand-Held, Low-Vision | 886.5870 | 1 | 0 |
| HKK | Telescope, Spectacle, Low-Vision | 886.5870 | 1 | 2 |
| HPF | Aid, Vision, Electronic, Ac-Powered | 886.5900 | 1 | 1 |
| HPG | Aid, Vision, Electronic, Battery-Powered | 886.5900 | 1 | 7 |
| PIC | Oral Electronic Vision Aid | 886.5905 | 2 | 2 |
| HOT | Aid, Vision Image Intensification | 886.5910 | 1 | 2 |
| HPE | Aid, Vision, Optical, Battery-Powered | 886.5915 | 1 | 1 |
| HPI | Aid, Vision, Optical, Ac-Powered | 886.5915 | 1 | 0 |
| HQD | Lens, Contact (Other Material) - Daily | 886.5916 | 2 | 120 |
| MUW | Lens, Contact (Orthokeratology) | 886.5916 | 2 | 6 |
| MWL | Lens, Contact (Rigid Gas Permeable), Extended Wear | 886.5916 | 3 | 6 |
| NUU | Lens, Contact, Orthokeratology, Overnight | 886.5916 | 3 | 4 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 886.5918 | 2 | 33 |
| QMM | Hydrophilic Re-Coating Solution | 886.5919 | 2 | 1 |
| LPL | Lenses, Soft Contact, Daily Wear | 886.5925 | 2 | 490 |
| LPM | Lenses, Soft Contact, Extended Wear | 886.5925 | 3 | 37 |
| MVN | Lens, Contact, (Disposable) | 886.5925 | 2 | 25 |
| MZD | System, In-Office Tinting, Contact Lenses | 886.5925 | 2 | 1 |
| NCZ | Lens, Contact, For Color Vision Deficiency | 886.5925 | 2 | 1 |
| NIC | Lens, Contact, For Reading Discomfort | 886.5925 | 2 | 1 |
| HRC | Sterilizer, Soft-Lens, Thermal, Battery-Powered | 886.5928 | 2 | 1 |
| HRD | Sterilizer, Soft-Lens, Thermal, Ac-Powered | 886.5928 | 2 | 1 |
| LPN | Accessories, Soft Lens Products | 886.5928 | 2 | 122 |
| LRX | Case, Contact Lens | 886.5928 | 2 | 82 |
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | 886.5928 | 2 | 22 |
