510(k) K213623
- Device
- ITEAR100 Neurostimulator
- Applicant
- Olympic Ophthalmics
- 510(k) number
- K213623
- Product code
- QKV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-16
- Date received
- 2021-11-16
- Regulation
- 886.5305
- Classification name
- Electromechanical Tear Stimulator
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Gertner
- Address
- 400 NW Gilman Blvd. No 1370 Issaquah WA US 98027 98027
Source Documents#
Other 510(k) Records For Product Code QKV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN190026 | iTEAR Neurostimulator | Olympic Ophthalmics, Inc. | 2020-05-01 |
Legacy Summary#
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FDA Review#
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