510(k) K213623
K213623 is an FDA 510(k) premarket notification submitted by Olympic Ophthalmics for the device "iTEAR100 Neurostimulator". The FDA issued a decision of Substantially Equivalent on March 16, 2022. The device falls under product code QKV (Electromechanical Tear Stimulator), a Class II device regulated under 21 CFR 886.5305. Olympic Ophthalmics has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2022
- Date Received
- November 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromechanical Tear Stimulator
- Device Class
- Class II
- Regulation Number
- 886.5305
- Review Panel
- OP
- Submission Type
This device type is a non-implantable device intended to increase tear production via mechanical stimulation.