FDA.reportPublic FDA data

Oral lesion examination light

Definition
A battery-powered, hand-held, torch-like device designed to visualize, and facilitate identification of, abnormalities of the oral mucosa (e.g., malignancy, dysplasia, bacterial and fungal infections) using one or more wavelengths (colours) of light. It may be supplied with disposable accessories (e.g., mirrors, tinted spectacles, lens covers). This is a reusable device.
GUDID devices
23
Last updated
2025-06-23 15:21:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
D702RT3001050StarDental Instrument SolutionsDENTALEZ, INC.RT3-001052016-09-13
D702RT3003710StarDental Instrument SolutionsDENTALEZ, INC.RT3-003712016-09-13
D702RT3003720StarDental Instrument SolutionsDENTALEZ, INC.RT3-003722016-09-13
D702RT3003860StarDental Instrument SolutionsDENTALEZ, INC.RT3-003862016-09-13
D702RT3003870StarDental Instrument SolutionsDENTALEZ, INC.RT3-003872016-09-13
D702RT3003900StarDental Instrument SolutionsDENTALEZ, INC.RT3-003902016-09-15
08051040582003G.o.c.c.l.e.s.PIERREL SPAG.o.c.c.l.e.s.2016-10-21
08051040582010G.o.c.c.l.e.s. lightPIERREL SPAG.o.c.c.l.e.s. light2016-10-21
D8136501180ViziLite®DEN-MAT HOLDINGS, LLC6501182022-09-22
D813PLS10030ViziLite®DEN-MAT HOLDINGS, LLCPLS10032022-09-22
D813PLS10050ViziLite®DEN-MAT HOLDINGS, LLCPLS10052022-09-22
D813PLS10080ViziLite®DEN-MAT HOLDINGS, LLCPLS10082022-09-22
00860179001075FUSION-DOE Light SystemDentlight Inc.77005122021-08-09
D86911009002AdDentADDENT, INC.Bio/Screen2017-06-01
D8136501010 ViziLite®DEN-MAT HOLDINGS, LLC6501012016-09-24
D8136501060 ViziLite®DEN-MAT HOLDINGS, LLC6501062016-09-24
D8136501991 ViziLite®DEN-MAT HOLDINGS, LLC6501992016-09-24
D813PLS10010VIZILITE PRO DEN-MAT HOLDINGS, LLCPLS10012016-11-14
07540201000018VELscopeLED Dental IncVELscope Vx2016-08-22
07540201000094VELscopeLED Dental IncVELscope Vx Value Bundle-Basic2016-12-21
00754020100010VELscopeLED Dental IncVELscope Vx2016-08-22
00754020100096VELscopeLED Dental IncVELscope Vx Value Bundle-Basic2016-12-21
00370275123163OralIDForward Science Technologies LLCFS-112016-10-03