K213623 is an FDA 510(k) clearance for the iTEAR100 Neurostimulator. This device is classified as a Electromechanical Tear Stimulator (Class II - Special Controls, product code QKV).
Submitted by Olympic Ophthalmics (Issaquah, US). The FDA issued a Cleared decision on March 16, 2022, 120 days after receiving the submission on November 16, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5305. This Device Type Is A Non-implantable Device Intended To Increase Tear Production Via Mechanical Stimulation..
| 510(k) Number | K213623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2021 |
| Decision Date | March 16, 2022 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | QKV - Electromechanical Tear Stimulator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5305 |
| Definition | This Device Type Is A Non-implantable Device Intended To Increase Tear Production Via Mechanical Stimulation. |