Home / Device Classification / FSY

FSY — Light, Surgical, Ceiling Mounted Class II

FDA Device Classification

Classification Details

Product Code
FSY
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
K142984sunnexLeo MinorOctober 29, 2014
K142076dickson and dickson healthcare (us)CLAVEGUARD FREEDOM SURGICAL LIGHTSeptember 30, 2014
K140812medical illumination internationalMI-750 PROCEDURAL/MINOR SURGICAL LIGHTAugust 7, 2014
K132551umbel corporationZF 720June 30, 2014
K140930convida healthcare and systems corporationVIDA LED SURGICAL LIGHTING SYSTEM, V SERIESJune 9, 2014
K140461mach gmbh and co. kgMACH LED 2MCApril 3, 2014
K140460mach gmbh and co. kgMACH LED 2SCApril 3, 2014
K132747stryker communicationsVISUM BLADE LED SURGICAL LIGHTING SYSTEMDecember 30, 2013
K132307convida healthcare and systems corporationVIDA LED SURGICAL LIGHTING SYSTEMNovember 5, 2013
K131893ajw technology consultantsAMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSOctober 30, 2013
K122875oricareORICARE L2700December 18, 2012
K120392berchtold gmbh and co. kgCHROMOPHARE F 628 AND F 528February 16, 2012
K102758trumpf kreuzer medizin systeme gmbh + co.kgTRULIGHT 5520 AND TRULIGHT 5320October 26, 2010
K101537burton medical productsAIM 200, MAJOR SURGICAL LIGHTSeptember 30, 2010
K100702huot instrumentsSTARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MOJuly 20, 2010
K093010mach gmbh and co. kgMACH LED MCApril 1, 2010
K093009mach gmbh and co. kgMACH LED SCApril 1, 2010
K090378berchtold gmbh and co. kgCHROMOPHARE E 668February 23, 2009
K083323nuvoNUVO VERDE LED LIGHTING SYSTEMJanuary 28, 2009
K083066berchtold holdingCHROMOPHARE E 778 AND E 558October 30, 2008