Skip to contentDe Novo DEN190026
- Device
- iTEAR Neurostimulator
- Contact
- michael gertner
- De Novo number
- DEN190026
- Product code
- QKV
- Regulation
- 886.5305
- Classification name
- electromechanical tear stimulator
- Decision
- granted (DENG)
- Decision date
- 2020-05-01
- Date received
- 2019-05-15
- Classification advisory
- Ophthalmic
- Review advisory
- Ophthalmic
- Type
- Direct
Current FDA Classification#
- Product code
- QKV
- Device name
- Electromechanical Tear Stimulator
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation
- 886.5305
- Implant
- N
- Life sustain/support
- N