FSP — Loupe, Diagnostic/Surgical Class I

FDA Device Classification

Classification Details

Product Code
FSP
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K895248luxtecIMS5000 ILLUMINATED LOUPESSeptember 15, 1989
K891895zinnanti surgical instrumentsSURGICAL LOUPESApril 12, 1989
K864386luxtecLUXTEC LOUPES FOR SURGICAL VISIONNovember 17, 1986
K861749keeler instruments3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCEMay 23, 1986