Definition: A Nasolacrimal Compression Device Is A Device Used To Compress The Nasolacrimal Ducts To Reduce Drainage By Means Of Temporary Occlusion Of The Nasolacrimal System. The Device May Include A Nose Piece Attached To A Frame To Apply Pressure To The Duct
| Device Type ID | 4406 |
| Device Name | Tear Duct Occluder |
| Physical State | The Frame Material (e.g., Metal) Is Durable And Flexible Enough To Appropriately Fit The Frame To The Patient And Maintain Nose Pad Placement. The Nose Pads From Which The Pressure Is Applied Should Include Padding To Mitigate Risk Of Abrasion. The D |
| Technical Method | A Device Of This Type Uses A Nose Piece To Apply Direct Pressure To The Top Of The Nasal Aspect Of The Orbital Rim To Occlude The Ducts During Application Of The Pressure. The Pressure Can Be Controlled By Means Of Tightening A Strap That Is Worn Aro |
| Target Area | Nasal Aspect Of Orbital Rim |
| Regulation Description | Nasolacrimal Compression Device. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 886.5838 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PLX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4406 |
| Device | Tear Duct Occluder |
| Product Code | PLX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nasolacrimal Compression Device. |
| CFR Regulation Number | 886.5838 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INNOVATEX INC. | ||
GRANTED | 1 | |