Definition: This Device Type Is Intended To Temporarily Increase Tear Production Using Neurostimulation In Adult Patients.
| Device Type ID | 4410 |
| Device Name | Intranasal Electrostimulation Device |
| Physical State | The Intranasal Tear Neurostimulator Is A Handheld Device With Two Electroconductive Tips That Are Inserted Into The Nasal Cavity During Neurostimulation. The Disposable Tips Are Made Of Rigid Biocompatible USP Class VI Plastic And The Conductive Tips |
| Technical Method | The Device Activates Tear Production Through Stimulation Of The Nasolacrimal Reflex. Stimulation Activates The Primary Sensory Afferent Fibers In The Ophthalmic And Maxillary Branches Of The Trigeminal Nerve (CNV1 And CNV2). The Device Design Limits |
| Target Area | Nose. |
| Regulation Description | Tear Electrostimulation 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) |
| CFR Regulation Number | 886.5300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4410 |
| Device | Intranasal Electrostimulation Device |
| Product Code | PQJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tear Electrostimulation Device. |
| CFR Regulation Number | 886.5300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALLERGAN, INC. | ||
GRANTED | 1 | |