Part 886 Subpart D—Prosthetic Devices
FDA submissions for Part 886 Subpart D—Prosthetic Devices in the Ophthalmic (OP) review panel, including product codes and regulations.
Section range: §§ 886.3100–886.3920
CFR Part: 886
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| HQW | Clip, Tantalum, Ophthalmic | 886.3100 | 2 | 3 |
| HQN | Conformer, Ophthalmic | 886.3130 | 2 | 7 |
| NQB | Conformer, Ophthalmic, Biological Tissue | 886.3130 | 2 | 1 |
| NXM | Prosthesis, Eyelid Spacer/Graft, Biologic | 886.3130 | 2 | 2 |
| QWU | Prosthesis, Eyelid Spacer/Graft, Polymer | 886.3130 | 2 | 1 |
| HQH | Eye, Artificial, Non-Custom | 886.3200 | 1 | 6 |
| NCK | Button, Iris, Eye, Artificial | 886.3200 | 1 | 1 |
| HQJ | Implant, Absorbable, (Scleral Buckling Methods) | 886.3300 | 2 | 5 |
| HPZ | Implant, Eye Sphere | 886.3320 | 2 | 39 |
| MQU | Ocular Peg | 886.3320 | 2 | 4 |
| MTZ | Wrap, Implant, Orbital | 886.3320 | 2 | 2 |
| NFM | Expander, Tissue, Orbital | 886.3320 | 2 | 2 |
| PUF | Ocular Peg, Exempt | 886.3320 | 2 | 0 |
| HQX | Implant, Orbital, Extra-Ocular | 886.3340 | 2 | 16 |
| HQM | Keratoprosthesis, Permanent Implant | 886.3400 | 2 | 4 |
| MLP | Keratoprosthesis, Temporary Implant, Surgical Use | 886.3400 | 2 | 4 |
| HQL | Intraocular Lens | 886.3600 | 3 | 65 |
| MFK | Lens, Multifocal Intraocular | 886.3600 | 3 | 5 |
| MJP | Lens, Intraocular, Toric Optics | 886.3600 | 3 | 0 |
| NAA | Lens, Intraocular, Accommodative | 886.3600 | 3 | 1 |
| NIZ | Lens, Iris Reconstruction | 886.3600 | 3 | 0 |
| POE | Extended Depth Of Focus Intraocular Lens | 886.3600 | 3 | 1 |
| PZK | Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) | 886.3600 | 3 | 1 |
| QCB | Phakic Toric Intraocular Lens | 886.3600 | 3 | 0 |
| HQT | Shell, Scleral | 886.3800 | 2 | 4 |
| KYF | Implant, Eye Valve | 886.3920 | 2 | 25 |
