Product Code: FSY FDA class 2 21 CFR 878.4580

Light, Surgical, Ceiling Mounted

General, Plastic Surgery

A ceiling-mounted surgical light is a fixed overhead lighting system installed in operating rooms to provide hands-free, overhead illumination of the surgical field from an adjustable ceiling mounting point. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FSY, regulated under 21 CFR 878.4580, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: FSY
Device Class: FDA class 2
Regulation Number: 878.4580
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 74 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K142984	Leo Minor	Oct 29, 2014	Substantially Equivalent	Sunnex, Inc.
K142076	CLAVEGUARD FREEDOM SURGICAL LIGHT	Sep 30, 2014	Substantially Equivalent	Dickson & Dickson Healthcare (Us), Inc.
K140812	MI-750 PROCEDURAL/MINOR SURGICAL LIGHT	Aug 07, 2014	Substantially Equivalent	Medical Illumination International, Inc.
K132551	ZF 720	Jun 30, 2014	Substantially Equivalent	Umbel Corporation
K140930	VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES	Jun 09, 2014	Substantially Equivalent	Convida Healthcare & Systems Corporation
K140461	MACH LED 2MC	Apr 03, 2014	Substantially Equivalent	Dr. Mach GmbH & Co. KG
K140460	MACH LED 2SC	Apr 03, 2014	Substantially Equivalent	Dr. Mach GmbH & Co. KG
K132747	VISUM BLADE LED SURGICAL LIGHTING SYSTEM	Dec 30, 2013	Substantially Equivalent	Stryker Communications
K132307	VIDA LED SURGICAL LIGHTING SYSTEM	Nov 05, 2013	Substantially Equivalent	Convida Healthcare & Systems Corporation
K131893	AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS	Oct 30, 2013	Substantially Equivalent	Ajw Technology Consultants, Inc.
K122875	ORICARE L2700	Dec 18, 2012	Substantially Equivalent	Oricare, Inc.
K120392	CHROMOPHARE F 628 AND F 528	Feb 16, 2012	Substantially Equivalent	Berchtold GmbH & Co. KG
K102758	TRULIGHT 5520 AND TRULIGHT 5320	Oct 26, 2010	Substantially Equivalent	Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
K101537	AIM 200, MAJOR SURGICAL LIGHT	Sep 30, 2010	Substantially Equivalent	Burton Medical Products Corp.
K100702	STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS	Jul 20, 2010	Substantially Equivalent	Huot Instruments, LLC
K093010	MACH LED MC	Apr 01, 2010	Substantially Equivalent	Dr. Mach GmbH & Co. KG
K093009	MACH LED SC	Apr 01, 2010	Substantially Equivalent	Dr. Mach GmbH & Co. KG
K090378	CHROMOPHARE E 668	Feb 23, 2009	Substantially Equivalent	Berchtold GmbH & Co. KG
K083323	NUVO VERDE LED LIGHTING SYSTEM	Jan 28, 2009	Substantially Equivalent	Nuvo, Inc.
K083066	CHROMOPHARE E 778 AND E 558	Oct 30, 2008	Substantially Equivalent	Berchtold Holding GmbH
K080857	CHROMOPHARE E-SERIES	Apr 10, 2008	Substantially Equivalent	Berchtold Holding GmbH
K072072	HARMONY LED-1 SURGICAL LIGHTING SYSTEM	Oct 05, 2007	Substantially Equivalent	STERIS Corporation
K071698	AURORA LED SERIES SURGICAL LIGHTS	Jul 06, 2007	Substantially Equivalent	Skytron, Div. the Kmw Group, Inc.
K070442	POWERLED SURGICAL LIGHT SYSTEM	Mar 16, 2007	Substantially Equivalent	Maquet S.A.
K063333	M3	Nov 21, 2006	Substantially Equivalent	Mavig GmbH
K061317	ILED	Jun 22, 2006	Substantially Equivalent	Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
K060802	VISUM LED SURGICAL LIGHTING SYSTEM	Apr 07, 2006	Substantially Equivalent	Stryker Communications Corp.
K042395	OUTPATIENT III MINOR SURGERY LIGHT	Dec 01, 2004	Substantially Equivalent	Burton Medical Products Corp.
K042382	DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD	Nov 30, 2004	Substantially Equivalent	Med-General Technologies, LLC
K040735	ALM X'TEN (X10) SURGICAL LIGHT SYSTEM	May 21, 2004	Substantially Equivalent	Alm S.A.
K040015	MODIFICATION TO PRISMALIX SURGICAL LIGHT	Jan 21, 2004	Substantially Equivalent	Alm S.A.
K031068	STRYKER VISUM SURGICAL LIGHTING SYSTEM	Aug 12, 2003	Substantially Equivalent	Stryker Endoscopy
K031979	CONMED INTEGRATED SYSTEMS NURSES ASSISTANT	Jul 25, 2003	Substantially Equivalent	Conmed Integrated Systems (Cmis)
K030906	AXCEL SURGICAL LIGHT	Apr 23, 2003	Substantially Equivalent	Alm
K024132	CHROMOPHARE X 65	Mar 21, 2003	Substantially Equivalent	Berchtold Holding GmbH
K021585	STELLAR SERIES SURGICAL LIGHTS WITH HERMES	Nov 13, 2002	Substantially Equivalent	Skytron, Div. the Kmw Group, Inc.
K011693	TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001	Jun 13, 2001	Substantially Equivalent	Trumpf Medical Systems, Inc.
K010716	VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB	May 30, 2001	Substantially Equivalent	Valmed Corp.
K002463	STELLAR	Nov 08, 2000	Substantially Equivalent	Skytron, Div. the Kmw Group, Inc.
K000639	VISIONARY 2000	May 25, 2000	Substantially Equivalent	Burton Medical Products Corp.
K993242	CASTLE SURGICAL LIGHT, MODEL 3000	Nov 08, 1999	Substantially Equivalent	Getinge/Castle, Inc.
K992090	MILLENNIUM GOLD	Sep 08, 1999	Substantially Equivalent	Skytron, Div. the Kmw Group, Inc.
K990656	CHROMOPHARE D 530 LDR SURGICAL LIGHT	Jul 20, 1999	Substantially Equivalent	Berchtold Holding GmbH
K991527	CHROMOPHARE D500, D530, D650	May 27, 1999	Substantially Equivalent	Berchtold Holding GmbH
K984611	DRAGER SOLA SERIES, MODELS 1000/700/500/300	Mar 29, 1999	Substantially Equivalent	Drager Medizintechnik GmbH
K982063	ALM PRISMALIX (PRX) SURGICAL LIGHT	Sep 22, 1998	Substantially Equivalent	Alm Surgical Equipment, Inc.
K981081	BRIGHTSTAR	Apr 29, 1998	Substantially Equivalent	Hill-Rom, Inc.
K974084	GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT	Mar 03, 1998	Substantially Equivalent	Getinge/Castle, Inc.
K974433	CHROMOPHARE D 500, CHROMOPHARE D 530	Feb 20, 1998	Substantially Equivalent	Berchtold Holding GmbH
K973466	HANAULUX BLUE 75 AND HANAULUX BLUE 120	Oct 24, 1997	Substantially Equivalent	Heraeus Med GmbH
K965130	CHROMOPHARE	Jul 14, 1997	Substantially Equivalent	Berchtold Holding GmbH
K963682	GENIE' SINGLE CEILING AND DOUBLE CEILING	Nov 13, 1996	Substantially Equivalent	Burton Medical Products Corp.
K961843	GENIE	Aug 22, 1996	Substantially Equivalent	Burton Medical Products Corp.
K954169	HANAULUX BLUE 30 & 80	Feb 01, 1996	Substantially Equivalent	Heraeus Med GmbH
K944855	CHROMOPHARE	Oct 19, 1994	Substantially Equivalent	Berchtold Holding GmbH
K943288	AMSCO SQ240 SURGICAL LIGHT	Oct 17, 1994	Substantially Equivalent	American Sterilizer Co.
K922836	CHROMOPHARE	Oct 09, 1992	Substantially Equivalent	Berchtold Holding GmbH
K915285	SKYTRON INFINITY SERIES SURGICAL LIGHTS	Feb 20, 1992	Substantially Equivalent	Skytron, Div. the Kmw Group, Inc.
K914076	MDT/CASTLE 2000 SURGICAL LIGHTS	Nov 13, 1991	Substantially Equivalent	Mdt Corp., Inc.
K904965	SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4	Jan 16, 1991	Substantially Equivalent	Smith & Nephew Equipment Group
K902864	SURGICAL LIGHTING-CENTRA 450	Sep 10, 1990	Substantially Equivalent	Sds Dental, Inc.
K901830	CHICK III SURGICAL LIGHTING SYSTEM	May 24, 1990	Substantially Equivalent	Chick Medical Products
K900211	SKYTRON UNIVERSE SERIES SURGICAL LIGHTS	Mar 19, 1990	Substantially Equivalent	Skytron, Div. the Kmw Group, Inc.
K896674	AMSCO QUANTUM LIGHT	Jan 03, 1990	Substantially Equivalent	American Sterilizer Co.
K892808	KINETIC MODEL 700	Jun 15, 1989	Substantially Equivalent	Kinetic Biomedical Services, Inc.
K891757	KINETIC MODEL 1000	Apr 19, 1989	Substantially Equivalent	Kinetic Biomedical Services, Inc.
K891756	KINETIC MODEL 500	Apr 19, 1989	Substantially Equivalent	Kinetic Biomedical Services, Inc.
K873786	SMITH & NEPHEW DAYLIGHTER(TM)	Oct 23, 1987	Substantially Equivalent	Smith & Nephew, Inc.
K860739	CHICK SURIGICAL LIGHT	Mar 28, 1986	Substantially Equivalent	Professional Medical Products, Inc.
K854922	AMSCO POLARIS SL	Jan 24, 1986	Substantially Equivalent	Amsco Co.
K820681	CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT	Apr 15, 1982	Substantially Equivalent	Sybron Corp.
K781887	9100 DAYSTAR AND 9110 ORBITER PACKAGE	Dec 12, 1978	Substantially Equivalent	Castle Co.
K780666	DAYSTAR SELECTRA & SELECTRA/ORBITER	Apr 27, 1978	Substantially Equivalent	Castle Co.
K771865	DAYSTAR SURG. LIGHT 9100 & ORBITER 9110	Nov 28, 1977	Substantially Equivalent	Castle Co.