Ali097lil_312968158.jpg

: This is a Class II medical device, which requires "general and special controls" to ensure safety and effectiveness.

Devices classified under the product code are used in medical settings to assess and record erectile function, typically to help clinicians distinguish between physiological and psychological causes of impotence. ali097LIL_312968158.jpg

While "ali097" and the subsequent numerical string ("312968158") are likely internal database identifiers or patient/lot numbers, the inclusion of is a standard practice in medical imaging and regulatory documentation to quickly identify the device type. Summary of Regulatory Classification Information Product Code LIL Device Name Monitor, Penile Tumescence FDA Review Panel Device Class Submission Type LIL - Product Classification - FDA : This is a Class II medical device,

: They are often used in Nocturnal Penile Tumescence (NPT) testing, where sensors measure changes in penile circumference and rigidity while the patient sleeps. Understanding the File Name String and Urology Devices.

: These monitors fall under the Urology category and are reviewed by the FDA's Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices.