PQJ — Intranasal Electrostimulation Device Class II
FDA product code PQJ covers "Intranasal Electrostimulation Device", a Class II medical device regulated under 21 CFR 886.5300. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PQJ
- Device Class
- Class II
- Regulation Number
- 886.5300
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
This device type is intended to temporarily increase tear production using neurostimulation in adult patients.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN160030 | oculeve | Oculeve Intranasal Tear Neurostimulator Device | April 24, 2017 |