510(k) DEN170086
DEN170086 is an FDA 510(k) premarket notification submitted by Allergan for the device "TrueTear Intranasal Tear Neurostimulator". The FDA issued a decision of De Novo Granted on May 17, 2018. The device falls under product code QBR (Intranasal Electrostimulation Device For Dry Eye Symptoms), a Class II device regulated under 21 CFR 886.5310. Allergan has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 17, 2018
- Date Received
- October 23, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intranasal Electrostimulation Device For Dry Eye Symptoms
- Device Class
- Class II
- Regulation Number
- 886.5310
- Review Panel
- OP
- Submission Type
This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.