QKV — Electromechanical Tear Stimulator Class II
FDA product code QKV covers "Electromechanical Tear Stimulator", a Class II medical device regulated under 21 CFR 886.5305. 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
- QKV
- Device Class
- Class II
- Regulation Number
- 886.5305
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
This device type is a non-implantable device intended to increase tear production via mechanical stimulation.