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FSW — Light, Surgical, Endoscopic Class II

FDA Device Classification

Classification Details

Product Code
FSW
Device Class
Class II
Regulation Number
878.4580
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K022989genzyme biosurgeryRADLITE TISSUE RETRACTOR SYSTEMNovember 25, 2002
K013511aculuxXENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)February 1, 2002
K943342m.p. videoMEDICAM XENON LIGHT SOURCEOctober 17, 1994
K934337cuda productsCUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCENovember 18, 1993
K922279medical illuminationILLUMINATOR IV MINOR SURGERY LIGHTSeptember 2, 1992
K913135leisegang medicalLM-300TWINSeptember 18, 1991
K894319medical dynamicsMEDICAL DYNAMICS LIGHT SOURCEOctober 3, 1989
K870898medline industriesULTRA-LUX LIGHT SOURCEMarch 18, 1987