Home / Device Classification / FTD

FTD — Lamp, Surgical Class II

FDA Device Classification

FDA product code FTD covers "Lamp, Surgical", a Class II medical device regulated under 21 CFR 878.4580. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FTD
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
K133425Engineered Medical Solutions CoSCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICALDec 5, 2013
K130513MaquetVOLISTA 400; VOLISTA 600May 8, 2013
K123776Drager MedicalPOLARIS 100/200Mar 8, 2013
K111020AtricureATRICURE DISSECTORJun 9, 2011
K100234HillusaHM-LAMP IIJul 8, 2010
K100884Howmedica OsteonicsSTRYKER KNIFELIGHTJun 25, 2010
K071180Engineered Medical Solutions CoSCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001Jun 20, 2007
K053364Waldmann LightingHALUX IRIS EXAMINATION AND SURGICAL LAMPFeb 23, 2006
K041681AtricureATRICURE DISSECTORJul 1, 2004
K013242Steris CorporationAMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEMDec 13, 2001
K010724Drager MedizintechnikSOLA 700,SOLA 500, SOLA 300Jun 7, 2001
K003423St. Francis Medical Equipment CoST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055Feb 22, 2001
K981717Stryker InstrumentsSTRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTORJun 30, 1998
K961122Stryker InstrumentsSTRYKER KNIFELIGHTAug 22, 1996
K954263Ophthalmic TechnologiesXE-LITEOct 18, 1995
K942553Burton Medical ProductsGENESISJun 23, 1994
K931675Medline IndustriesMEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPSFeb 22, 1994
K932451Heraeus InstrumentsHANAULUX 2005 SURGICAL LIGHTNov 12, 1993
K930897Medical IlluminationMI-15 EXAM SURGICAL LIGHTJun 25, 1993
K895715W.C. HeraeusHANAULUX(R) 2000Oct 13, 1989

FDA data resources