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NXV — Diagnostic Light, Soft Tissue Detector Class II

FDA Device Classification

Classification Details

Product Code
NXV
Device Class
Class II
Regulation Number
872.6350
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K151630pierrel pharmaG.o.c.c.l.e.s.September 15, 2015
K123169forward scienceORALIDMarch 13, 2013
K121282addentMICROLUX/DL MICROLUX/BLU BIO/SCREENJuly 24, 2012
K102083led dentalVELSCOPE VXNovember 18, 2010
K101140dentlightDENTLIGHT ORAL EXAM LIGHT KITJuly 15, 2010
K090135remicalmTRIMIRA IDENTAFI 3000February 17, 2009
K082668addentBIO-SCREENJanuary 23, 2009
K082603remicalmTRIMIRA OCS 3000December 12, 2008
K080043zilaVIZILITE EYEWEARApril 4, 2008
K073483den-mat holdingsSAPPHIRE O/E ORAL EXAMINATION SYSTEMApril 3, 2008
K070523led dentalMODIFICATION TO: VELSCOPEApril 5, 2007
K060920led medical diagnosticsVELSCOPEApril 27, 2006