510(k) DEN190026
DEN190026 is an FDA 510(k) premarket notification submitted by Olympic Ophthalmics, Inc. for the device "iTEAR Neurostimulator". The FDA issued a decision of De Novo Granted on May 1, 2020. The device falls under product code QKV (Electromechanical Tear Stimulator), a Class II device regulated under 21 CFR 886.5305. Olympic Ophthalmics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 1, 2020
- Date Received
- May 15, 2019
- Clearance Type
- Direct
- 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.