Device |
electromechanical tear stimulator |
Regulation Description |
Electromechanical tear stimulator. |
Definition |
This device type is a non-implantable device intended to increase tear production via mechanical stimulation. |
Physical State |
The device is a battery-operated handheld electromechanical actuator with a vibratory tip, and software controller. |
Technical Method |
The device activates tear production through stimulation of the nasolacrimal reflex. Stimulation mechanically activates external nasal nerve and initiates the nasolacrimal reflex, resulting in tear secretion. To produce the intended effect, the vibratory tip of the device should be applied to the lateral aspect of the nose for several seconds. |
Target Area |
Lateral aspect of the nose. |
Regulation Medical Specialty |
Ophthalmic |
Review Panel |
Ophthalmic |
Product Code | QKV |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
Submission Type |
510(k)
|
Regulation Number |
886.5305
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |