TrueTear Intranasal Tear Neurostimulator
FDA 510(k) clearance DEN170086 · decided 2018-05-17
Clearance details
- K-number
- DEN170086
- Device name
- TrueTear Intranasal Tear Neurostimulator
- Applicant
- Allergan
- Decision
- Unknown
- Date received
- 2017-10-23
- Decision date
- 2018-05-17
- Days to decision
- 206 days
- Clearance type
- Direct
- Product code
- QBR
- Device class
- 2
- Regulation number
- 886.5310
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TrueTear Intranasal Tear Neurostimulator (K193589) | Allergan | 2020-08-31 |
Recalls involving this device
No recalls on record reference this clearance.