FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
TrueTear Intranasal Tear Neurostimulator
K Number: DEN170086
·
Decision May 17, 2018
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
6
Review Days
206
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Basic Information
- Device Name
- TrueTear Intranasal Tear Neurostimulator
- K Number
- DEN170086
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 886.5310
- Medical Specialty
- Ophthalmic
- Decision
- Unknown
- Applicant
- Allergan
- Date Received
- October 23, 2017
- Decision Date
- May 17, 2018
- Product Code
- QBR
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QBR | Intranasal Electrostimulation Device For Dry Eye Symptoms | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QBR), ordered by most recent decision date.
View allOther Clearances by Allergan
| K Number | Device Name | ||
|---|---|---|---|
| K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | Jun 2, 2021 | Substantially Equivalent |
| K193589 | TrueTear Intranasal Tear Neurostimulator | Aug 31, 2020 | Substantially Equivalent |
| K180826 | Natrelle 133 Plus MICROCELL Tissue Expander | Dec 21, 2018 | Substantially Equivalent |
| K182054 | Natrelle 133S Tissue Expander | Aug 29, 2018 | Substantially Equivalent |
| K123128 | SERI SURGICAL SCAFFOLD | Apr 25, 2013 | Substantially Equivalent |