21 CFR 886.5838 — Tear Duct Occluder
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5838
Identification
A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| PLX | Tear Duct Occluder | 1 | 1 |
