QBR — Intranasal Electrostimulation Device For Dry Eye Symptoms Class II
FDA product code QBR covers "Intranasal Electrostimulation Device For Dry Eye Symptoms", a Class II medical device regulated under 21 CFR 886.5310. Submissions are reviewed by the Ophthalmic panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QBR
- Device Class
- Class II
- Regulation Number
- 886.5310
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.