NXV

Diagnostic Light, Soft Tissue Detector

Product code

NXV

Device name

Diagnostic Light, Soft Tissue Detector

Device class

Class 2

21 CFR

21 CFR 872.6350

Medical specialty

Dental

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

12 (all years; only the last 3 years are listed here)

FDA classification definition

To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities

Definition text from the FDA device classification database (U.S. federal government work, public domain).