510(k) K193589
- Device
- TrueTear Intranasal Tear Neurostimulator
- Applicant
- Allergan
- 510(k) number
- K193589
- Product code
- QBR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-08-31
- Date received
- 2019-12-23
- Regulation
- 886.5310
- Classification name
- Intranasal Electrostimulation Device For Dry Eye Symptoms
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Barbara Simon
- Address
- 2525 Dupont Dr. Irvine CA US 92612 92612
Source Documents#
Other 510(k) Records For Product Code QBR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN170086 | TrueTear Intranasal Tear Neurostimulator | Allergan | 2018-05-17 |