iTEAR100 Neurostimulator
FDA 510(k) clearance K213623 · decided 2022-03-16
Clearance details
- K-number
- K213623
- Device name
- iTEAR100 Neurostimulator
- Applicant
- Olympic Ophthalmics
- Decision
- Substantially Equivalent
- Date received
- 2021-11-16
- Decision date
- 2022-03-16
- Days to decision
- 120 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| iTEAR Neurostimulator (DEN190026) | Olympic Ophthalmics, Inc. | 2020-05-01 |
Recalls involving this device
No recalls on record reference this clearance.