Intranasal Electrostimulation Device
The Intranasal Electrostimulation Device is a non-implanted device intended to temporarily increase tear production through neurostimulation of the nasal passages in adult patients with dry eye, classified in the Ophthalmic specialty. It is classified as FDA Class 2 under 21 CFR 886.5300, requiring 510(k) premarket notification. The device offers a drug-free approach to stimulating the lacrimal glands via the nasolacrimal reflex. Product code PQJ; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQJ
- Device Class
- FDA class 2
- Regulation Number
- 886.5300
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Definition
This device type is intended to temporarily increase tear production using neurostimulation in adult patients.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN160030 | Oculeve Intranasal Tear Neurostimulator Device | Apr 24, 2017 | Unknown | Oculeve, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.