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FCT — Headlight, Fiberoptic Focusing Class II

FDA Device Classification

Classification Details

Product Code
FCT
Device Class
Class II
Regulation Number
886.4335
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K960767scieran technologiesLIGHT COMMANDERAugust 26, 1996
K924198chiron visionMODIFIED SITE FIBER OPTIC MODULENovember 23, 1992
K883480site microsurgical systemsMODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USEAugust 24, 1988
K802770aspen laboratoriesFIBER OPTIC HEADLIGHT #60-0766766December 11, 1980
K802769aspen laboratoriesFIBER OPTIC HEADLIGHT #60-0765December 11, 1980
K780433cameron-millerFIBER OPTIC ADJUSTABLE HEADLIGHTJune 13, 1978