PQJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intranasal Electrostimulation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5300
- Medical specialty
- Ophthalmic
- FDA definition
- This device type is intended to temporarily increase tear production using neurostimulation in adult patients.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Oculeve Intranasal Tear Neurostimulator Device (DEN160030) | Oculeve, Inc. | 2017-04-24 |
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