TrueTear Intranasal Tear Neurostimulator
FDA 510(k) K193589 · Allergan
510(k) numberK193589
Submission
- Device name
- TrueTear Intranasal Tear Neurostimulator
- Applicant
- Allergan
Irvine, CA, US - Received
- December 23, 2019
- Decision date
- August 31, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QBR – Intranasal Electrostimulation Device For Dry Eye Symptoms
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5310
- Specialty
- Ophthalmic
This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.
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Questions and answers
When was TrueTear Intranasal Tear Neurostimulator cleared by the FDA?
TrueTear Intranasal Tear Neurostimulator (K193589) received a 510(k) decision of Substantially Equivalent on August 31, 2020, 252 days after the submission was received.
What is the product code of K193589?
The FDA product code is QBR – Intranasal Electrostimulation Device For Dry Eye Symptoms, a Class II (moderate risk) device regulated under 21 CFR 886.5310.