iTEAR100 Neurostimulator— 510(k) K213623
Substantially EquivalentOlympic Ophthalmics
FDA 510(k) clearance K213623 for iTEAR100 Neurostimulator, Substantially Equivalent on 2022-03-16. Applicant: Olympic Ophthalmics. Device class: 2.
Clearance details
- Applicant
- Olympic Ophthalmics
- Product code
- Code QKV
- Device class
- Class 2
- Regulation
- 21 CFR 886.5305
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Issaquah, WA, US
Recent devices under product code QKV
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