Light, Surgical, Ceiling Mounted
FDA product code FSY · 67 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.4580
- Review panel
- SU
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1977-11-28 – 2013-12-30
FSY
2013-12-30
FSY
2013-11-05
VIDA LED SURGICAL LIGHTING SYSTEM
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FSY
2013-10-30
AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
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FSY
2012-12-18
ORICARE L2700
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FSY
2012-02-16
CHROMOPHARE F 628 AND F 528
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FSY
2010-10-26
TRULIGHT 5520 AND TRULIGHT 5320
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FSY
2010-09-30
AIM 200, MAJOR SURGICAL LIGHT
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FSY
2010-07-20
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
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FSY
2010-04-01
MACH LED MC
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FSY
2010-04-01
MACH LED SC
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FSY
2009-02-23
CHROMOPHARE E 668
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FSY
2009-01-28
NUVO VERDE LED LIGHTING SYSTEM
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FSY
2008-10-30
CHROMOPHARE E 778 AND E 558
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FSY
2008-04-10
CHROMOPHARE E-SERIES
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FSY
2007-10-05
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
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FSY
2007-07-06
AURORA LED SERIES SURGICAL LIGHTS
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FSY
2007-03-16
POWERLED SURGICAL LIGHT SYSTEM
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FSY
2006-11-21
M3
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FSY
2006-06-22
ILED
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FSY
2006-04-07
VISUM LED SURGICAL LIGHTING SYSTEM
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FSY
2004-12-01
OUTPATIENT III MINOR SURGERY LIGHT
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FSY
2004-11-30
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
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FSY
2004-05-21
ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
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FSY
2004-01-21
MODIFICATION TO PRISMALIX SURGICAL LIGHT
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FSY
2003-08-12
STRYKER VISUM SURGICAL LIGHTING SYSTEM
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FSY
2003-07-25
CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
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FSY
2003-04-23
AXCEL SURGICAL LIGHT
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FSY
2003-03-21
CHROMOPHARE X 65
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FSY
2002-11-13
STELLAR SERIES SURGICAL LIGHTS WITH HERMES
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FSY
2001-06-13
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
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FSY
2001-05-30
VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB
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FSY
2000-11-08
STELLAR
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FSY
2000-05-25
VISIONARY 2000
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FSY
1999-11-08
CASTLE SURGICAL LIGHT, MODEL 3000
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FSY
1999-09-08
MILLENNIUM GOLD
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FSY
1999-07-20
CHROMOPHARE D 530 LDR SURGICAL LIGHT
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FSY
1999-05-27
CHROMOPHARE D500, D530, D650
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FSY
1999-03-29
DRAGER SOLA SERIES, MODELS 1000/700/500/300
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FSY
1998-09-22
ALM PRISMALIX (PRX) SURGICAL LIGHT
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FSY
1998-04-29
BRIGHTSTAR
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FSY
1998-03-03
GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
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FSY
1998-02-20
CHROMOPHARE D 500, CHROMOPHARE D 530
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FSY
1997-10-24
HANAULUX BLUE 75 AND HANAULUX BLUE 120
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FSY
1997-07-14
CHROMOPHARE
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FSY
1996-11-13
GENIE' SINGLE CEILING AND DOUBLE CEILING
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FSY
1996-08-22
GENIE
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FSY
1996-02-01
HANAULUX BLUE 30 & 80
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FSY
1994-10-19
CHROMOPHARE
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FSY
1994-10-17
AMSCO SQ240 SURGICAL LIGHT
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FSY
1992-10-09
CHROMOPHARE
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FSY
1992-02-20
SKYTRON INFINITY SERIES SURGICAL LIGHTS
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FSY
1991-11-13
MDT/CASTLE 2000 SURGICAL LIGHTS
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FSY
1991-01-16
SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4
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FSY
1990-09-10
SURGICAL LIGHTING-CENTRA 450
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FSY
1990-05-24
CHICK III SURGICAL LIGHTING SYSTEM
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FSY
1990-03-19
SKYTRON UNIVERSE SERIES SURGICAL LIGHTS
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FSY
1990-01-03
AMSCO QUANTUM LIGHT
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FSY
1989-06-15
KINETIC MODEL 700
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FSY
1989-04-19
KINETIC MODEL 1000
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FSY
1989-04-19
KINETIC MODEL 500
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FSY
1987-10-23
SMITH & NEPHEW DAYLIGHTER(TM)
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FSY
1986-03-28
CHICK SURIGICAL LIGHT
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FSY
1986-01-24
AMSCO POLARIS SL
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FSY
1982-04-15
CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT
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FSY
1978-12-12
9100 DAYSTAR AND 9110 ORBITER PACKAGE
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FSY
1978-04-27
DAYSTAR SELECTRA & SELECTRA/ORBITER
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FSY
1977-11-28
DAYSTAR SURG. LIGHT 9100 & ORBITER 9110
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