iTEAR Neurostimulator
FDA 510(k) clearance DEN190026 · decided 2020-05-01
Clearance details
- K-number
- DEN190026
- Device name
- iTEAR Neurostimulator
- Applicant
- Olympic Ophthalmics, Inc.
- Decision
- Unknown
- Date received
- 2019-05-15
- Decision date
- 2020-05-01
- Days to decision
- 352 days
- Clearance type
- Direct
- Product code
- QKV
- Device class
- 2
- Regulation number
- 886.5305
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Issaquah, WA, 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 |
|---|---|---|
| iTEAR100 Neurostimulator (K213623) | Olympic Ophthalmics | 2022-03-16 |
Recalls involving this device
No recalls on record reference this clearance.