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FSS — Light, Surgical, Floor Standing Class II

FDA Device Classification

Classification Details

Product Code
FSS
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
K091246trumpf medizin systeme gmbh + co. kgILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300MSeptember 28, 2009
K003489medical illumination internationalNEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GFebruary 2, 2001
K984124aesculapAESCULAP XENON LIGHT SOURCEFebruary 1, 1999
K981962cuda productsCUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCEAugust 18, 1998
K981821angiolazVES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORJuly 29, 1998
K981469cuda productsCERMAX300 LIGHTSOURCEJuly 9, 1998
K980044perkinelmer optoelectronicsXENON 300MXApril 3, 1998
K970886heraeus medHANAULUX BLUE 80 HOSPITALApril 16, 1997
K961971stryker endoscopyQ-5000June 28, 1996
K961074cuda productsLIGHTSOURCE OR ILLUMINATORApril 30, 1996
K930711light technology systemsTRI*STARJuly 30, 1993
K910942mdt biologicAC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHTJune 11, 1991
K895950f.w. langMODEL FEL5100 FLOOR LIGHTOctober 31, 1989
K893813astraliteFLOOR STANDING, OPERATING AND EXAMINING LIGHTJuly 14, 1989
K891759kinetic biomedical servicesKINETIC MODEL 330April 19, 1989
K891758kinetic biomedical servicesKINETIC MODEL 132April 19, 1989
K882333commercial products and engineeringFLOOR LIGHTJune 23, 1988
K880540ferguson medicalLIGHT, SURGICAL, FLOOR STANDINGFebruary 24, 1988
K880198american sterilizerGEMINI SURGICAL LIGHTFebruary 10, 1988
K860020adel medicalMINOR SURGERY LIGHT MODEL 2112January 24, 1986