Electromechanical Tear Stimulator
The Electromechanical Tear Stimulator is a Class 2 ophthalmic device that is non-implantable and intended to increase tear production via mechanical stimulation, used in the management of dry eye conditions by stimulating the lacrimal glands. It requires 510(k) clearance and is regulated under 21 CFR 886.5305 within the Ophthalmic medical specialty. The product code is QKV. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QKV
- Device Class
- FDA class 2
- Regulation Number
- 886.5305
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Definition
This device type is a non-implantable device intended to increase tear production via mechanical stimulation.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.