General, Plastic Surgery

FSY · Light, Surgical, Ceiling Mounted

General, Plastic Surgery · 21 CFR 878.4580 · Class 2

Overview

Product CodeFSY
Device NameLight, Surgical, Ceiling Mounted
Regulation21 CFR 878.4580
Device ClassClass 2
Review PanelGeneral, Plastic Surgery

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Classification Rationale

Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Cleared Devices (74)

RecordDevice NameApplicantDecision DateDecision
K142984Leo MinorSunnex, Inc.Oct 29, 2014SESE
K142076CLAVEGUARD FREEDOM SURGICAL LIGHTDickson & Dickson Healthcare (Us), Inc.Sep 30, 2014SESE
K140812MI-750 PROCEDURAL/MINOR SURGICAL LIGHTMedical Illumination International, Inc.Aug 7, 2014SESE
K132551ZF 720Umbel CorporationJun 30, 2014SESE
K140930VIDA LED SURGICAL LIGHTING SYSTEM, V SERIESConvida Healthcare & Systems CorporationJun 9, 2014SESE
K140461MACH LED 2MCDr. Mach GmbH & Co. KGApr 3, 2014SESE
K140460MACH LED 2SCDr. Mach GmbH & Co. KGApr 3, 2014SESE
K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker CommunicationsDec 30, 2013SESE
K132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems CorporationNov 5, 2013SESE
K131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.Oct 30, 2013SESE
K122875ORICARE L2700Oricare, Inc.Dec 18, 2012SESE
K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KGFeb 16, 2012SESE
K102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.KgOct 26, 2010SESE
K101537AIM 200, MAJOR SURGICAL LIGHTBurton Medical Products Corp.Sep 30, 2010SESE
K100702STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODSHuot Instruments, LLCJul 20, 2010SESE
K093010MACH LED MCDr. Mach GmbH & Co. KGApr 1, 2010SESE
K093009MACH LED SCDr. Mach GmbH & Co. KGApr 1, 2010SESE
K090378CHROMOPHARE E 668Berchtold GmbH & Co. KGFeb 23, 2009SESE
K083323NUVO VERDE LED LIGHTING SYSTEMNuvo, Inc.Jan 28, 2009SESE
K083066CHROMOPHARE E 778 AND E 558Berchtold Holding GmbHOct 30, 2008SESE
K080857CHROMOPHARE E-SERIESBerchtold Holding GmbHApr 10, 2008SESE
K072072HARMONY LED-1 SURGICAL LIGHTING SYSTEMSTERIS CorporationOct 5, 2007SESE
K071698AURORA LED SERIES SURGICAL LIGHTSSkytron, Div. the Kmw Group, Inc.Jul 6, 2007SESE
K070442POWERLED SURGICAL LIGHT SYSTEMMaquet S.A.Mar 16, 2007SESE
K063333M3Mavig GmbHNov 21, 2006SESE
K061317ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.KgJun 22, 2006SESE
K060802VISUM LED SURGICAL LIGHTING SYSTEMStryker Communications Corp.Apr 7, 2006SESE
K042395OUTPATIENT III MINOR SURGERY LIGHTBurton Medical Products Corp.Dec 1, 2004SESE
K042382DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEADMed-General Technologies, LLCNov 30, 2004SESE
K040735ALM X'TEN (X10) SURGICAL LIGHT SYSTEMAlm S.A.May 21, 2004SESE
K040015MODIFICATION TO PRISMALIX SURGICAL LIGHTAlm S.A.Jan 21, 2004SESE
K031068STRYKER VISUM SURGICAL LIGHTING SYSTEMStryker EndoscopyAug 12, 2003SESE
K031979CONMED INTEGRATED SYSTEMS NURSES ASSISTANTConmed Integrated Systems (Cmis)Jul 25, 2003SESE
K030906AXCEL SURGICAL LIGHTAlmApr 23, 2003SESE
K024132CHROMOPHARE X 65Berchtold Holding GmbHMar 21, 2003SESE
K021585STELLAR SERIES SURGICAL LIGHTS WITH HERMESSkytron, Div. the Kmw Group, Inc.Nov 13, 2002SESE
K011693TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001Trumpf Medical Systems, Inc.Jun 13, 2001SESE
K010716VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUBValmed Corp.May 30, 2001SESE
K002463STELLARSkytron, Div. the Kmw Group, Inc.Nov 8, 2000SESE
K000639VISIONARY 2000Burton Medical Products Corp.May 25, 2000SESE
K993242CASTLE SURGICAL LIGHT, MODEL 3000Getinge/Castle, Inc.Nov 8, 1999SESE
K992090MILLENNIUM GOLDSkytron, Div. the Kmw Group, Inc.Sep 8, 1999SESE
K990656CHROMOPHARE D 530 LDR SURGICAL LIGHTBerchtold Holding GmbHJul 20, 1999SESE
K991527CHROMOPHARE D500, D530, D650Berchtold Holding GmbHMay 27, 1999SESE
K984611DRAGER SOLA SERIES, MODELS 1000/700/500/300Drager Medizintechnik GmbHMar 29, 1999SESE
K982063ALM PRISMALIX (PRX) SURGICAL LIGHTAlm Surgical Equipment, Inc.Sep 22, 1998SESE
K981081BRIGHTSTARHill-Rom, Inc.Apr 29, 1998SESE
K974084GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHTGetinge/Castle, Inc.Mar 3, 1998SESE
K974433CHROMOPHARE D 500, CHROMOPHARE D 530Berchtold Holding GmbHFeb 20, 1998SESE
K973466HANAULUX BLUE 75 AND HANAULUX BLUE 120Heraeus Med GmbHOct 24, 1997SESE
K965130CHROMOPHAREBerchtold Holding GmbHJul 14, 1997SESE
K963682GENIE' SINGLE CEILING AND DOUBLE CEILINGBurton Medical Products Corp.Nov 13, 1996SESE
K961843GENIEBurton Medical Products Corp.Aug 22, 1996SESE
K954169HANAULUX BLUE 30 & 80Heraeus Med GmbHFeb 1, 1996SESE
K944855CHROMOPHAREBerchtold Holding GmbHOct 19, 1994SESE
K943288AMSCO SQ240 SURGICAL LIGHTAmerican Sterilizer Co.Oct 17, 1994SESE
K922836CHROMOPHAREBerchtold Holding GmbHOct 9, 1992SESE
K915285SKYTRON INFINITY SERIES SURGICAL LIGHTSSkytron, Div. the Kmw Group, Inc.Feb 20, 1992SESE
K914076MDT/CASTLE 2000 SURGICAL LIGHTSMdt Corp., Inc.Nov 13, 1991SESE
K904965SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4Smith & Nephew Equipment GroupJan 16, 1991SESE
K902864SURGICAL LIGHTING-CENTRA 450Sds Dental, Inc.Sep 10, 1990SESE
K901830CHICK III SURGICAL LIGHTING SYSTEMChick Medical ProductsMay 24, 1990SESE
K900211SKYTRON UNIVERSE SERIES SURGICAL LIGHTSSkytron, Div. the Kmw Group, Inc.Mar 19, 1990SESE
K896674AMSCO QUANTUM LIGHTAmerican Sterilizer Co.Jan 3, 1990SESE
K892808KINETIC MODEL 700Kinetic Biomedical Services, Inc.Jun 15, 1989SESE
K891757KINETIC MODEL 1000Kinetic Biomedical Services, Inc.Apr 19, 1989SESE
K891756KINETIC MODEL 500Kinetic Biomedical Services, Inc.Apr 19, 1989SESE
K873786SMITH & NEPHEW DAYLIGHTER(TM)Smith & Nephew, Inc.Oct 23, 1987SESE
K860739CHICK SURIGICAL LIGHTProfessional Medical Products, Inc.Mar 28, 1986SESE
K854922AMSCO POLARIS SLAmsco Co.Jan 24, 1986SESE
K820681CASTLE(R) 2510 & 2610 MINOR SURG. LIGHTSybron Corp.Apr 15, 1982SESE
K7818879100 DAYSTAR AND 9110 ORBITER PACKAGECastle Co.Dec 12, 1978SESE
K780666DAYSTAR SELECTRA & SELECTRA/ORBITERCastle Co.Apr 27, 1978SESE
K771865DAYSTAR SURG. LIGHT 9100 & ORBITER 9110Castle Co.Nov 28, 1977SESE

Top Applicants

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