Atlas FDA

FSY

74 FDA 510(k) clearances · Product code

63 daysmedian time to decision
130 days90th percentile
74clearances measured

FDA profile

Official device name
Light, Surgical, Ceiling Mounted
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 380 · 2022: 430 · 2023: 663 · 2024: 541 · 2025: 292 · 2026: 148
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Leo Minor (K142984)Sunnex, Inc.2014-10-29
CLAVEGUARD FREEDOM SURGICAL LIGHT (K142076)Dickson & Dickson Healthcare (Us), Inc.2014-09-30
MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (K140812)Medical Illumination International, Inc.2014-08-07
ZF 720 (K132551)Umbel Corporation2014-06-30
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (K140930)Convida Healthcare & Systems Corporation2014-06-09
MACH LED 2SC (K140460)Dr. Mach GmbH & Co. KG2014-04-03
MACH LED 2MC (K140461)Dr. Mach GmbH & Co. KG2014-04-03
VISUM BLADE LED SURGICAL LIGHTING SYSTEM (K132747)Stryker Communications2013-12-30
VIDA LED SURGICAL LIGHTING SYSTEM (K132307)Convida Healthcare & Systems Corporation2013-11-05
AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (K131893)Ajw Technology Consultants, Inc.2013-10-30
ORICARE L2700 (K122875)Oricare, Inc.2012-12-18
CHROMOPHARE F 628 AND F 528 (K120392)Berchtold GmbH & Co. KG2012-02-16
TRULIGHT 5520 AND TRULIGHT 5320 (K102758)Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg2010-10-26
AIM 200, MAJOR SURGICAL LIGHT (K101537)Burton Medical Products Corp.2010-09-30
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 (K100702)Huot Instruments, LLC2010-07-20
MACH LED SC (K093009)Dr. Mach GmbH & Co. KG2010-04-01
MACH LED MC (K093010)Dr. Mach GmbH & Co. KG2010-04-01
CHROMOPHARE E 668 (K090378)Berchtold GmbH & Co. KG2009-02-23
NUVO VERDE LED LIGHTING SYSTEM (K083323)Nuvo, Inc.2009-01-28
CHROMOPHARE E 778 AND E 558 (K083066)Berchtold Holding GmbH2008-10-30
CHROMOPHARE E-SERIES (K080857)Berchtold Holding GmbH2008-04-10
HARMONY LED-1 SURGICAL LIGHTING SYSTEM (K072072)STERIS Corporation2007-10-05
AURORA LED SERIES SURGICAL LIGHTS (K071698)Skytron, Div. the Kmw Group, Inc.2007-07-06
POWERLED SURGICAL LIGHT SYSTEM (K070442)Maquet S.A.2007-03-16
M3 (K063333)Mavig GmbH2006-11-21
ILED (K061317)Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg2006-06-22
VISUM LED SURGICAL LIGHTING SYSTEM (K060802)Stryker Communications Corp.2006-04-07
OUTPATIENT III MINOR SURGERY LIGHT (K042395)Burton Medical Products Corp.2004-12-01
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD (K042382)Med-General Technologies, LLC2004-11-30
ALM X'TEN (X10) SURGICAL LIGHT SYSTEM (K040735)Alm S.A.2004-05-21
MODIFICATION TO PRISMALIX SURGICAL LIGHT (K040015)Alm S.A.2004-01-21
STRYKER VISUM SURGICAL LIGHTING SYSTEM (K031068)Stryker Endoscopy2003-08-12
CONMED INTEGRATED SYSTEMS NURSES ASSISTANT (K031979)Conmed Integrated Systems (Cmis)2003-07-25
AXCEL SURGICAL LIGHT (K030906)Alm2003-04-23
CHROMOPHARE X 65 (K024132)Berchtold Holding GmbH2003-03-21
STELLAR SERIES SURGICAL LIGHTS WITH HERMES (K021585)Skytron, Div. the Kmw Group, Inc.2002-11-13
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 (K011693)Trumpf Medical Systems, Inc.2001-06-13
VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB (K010716)Valmed Corp.2001-05-30
STELLAR (K002463)Skytron, Div. the Kmw Group, Inc.2000-11-08
VISIONARY 2000 (K000639)Burton Medical Products Corp.2000-05-25
CASTLE SURGICAL LIGHT, MODEL 3000 (K993242)Getinge/Castle, Inc.1999-11-08
MILLENNIUM GOLD (K992090)Skytron, Div. the Kmw Group, Inc.1999-09-08
CHROMOPHARE D 530 LDR SURGICAL LIGHT (K990656)Berchtold Holding GmbH1999-07-20
CHROMOPHARE D500, D530, D650 (K991527)Berchtold Holding GmbH1999-05-27
DRAGER SOLA SERIES, MODELS 1000/700/500/300 (K984611)Drager Medizintechnik GmbH1999-03-29
ALM PRISMALIX (PRX) SURGICAL LIGHT (K982063)Alm Surgical Equipment, Inc.1998-09-22
BRIGHTSTAR (K981081)Hill-Rom, Inc.1998-04-29
GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT (K974084)Getinge/Castle, Inc.1998-03-03
CHROMOPHARE D 500, CHROMOPHARE D 530 (K974433)Berchtold Holding GmbH1998-02-20
HANAULUX BLUE 75 AND HANAULUX BLUE 120 (K973466)Heraeus Med GmbH1997-10-24
CHROMOPHARE (K965130)Berchtold Holding GmbH1997-07-14
GENIE' SINGLE CEILING AND DOUBLE CEILING (K963682)Burton Medical Products Corp.1996-11-13
GENIE (K961843)Burton Medical Products Corp.1996-08-22
HANAULUX BLUE 30 & 80 (K954169)Heraeus Med GmbH1996-02-01
CHROMOPHARE (K944855)Berchtold Holding GmbH1994-10-19
AMSCO SQ240 SURGICAL LIGHT (K943288)American Sterilizer Co.1994-10-17
CHROMOPHARE (K922836)Berchtold Holding GmbH1992-10-09
SKYTRON INFINITY SERIES SURGICAL LIGHTS (K915285)Skytron, Div. the Kmw Group, Inc.1992-02-20
MDT/CASTLE 2000 SURGICAL LIGHTS (K914076)Mdt Corp., Inc.1991-11-13
SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 (K904965)Smith & Nephew Equipment Group1991-01-16
SURGICAL LIGHTING-CENTRA 450 (K902864)Sds Dental, Inc.1990-09-10
CHICK III SURGICAL LIGHTING SYSTEM (K901830)Chick Medical Products1990-05-24
SKYTRON UNIVERSE SERIES SURGICAL LIGHTS (K900211)Skytron, Div. the Kmw Group, Inc.1990-03-19
AMSCO QUANTUM LIGHT (K896674)American Sterilizer Co.1990-01-03
KINETIC MODEL 700 (K892808)Kinetic Biomedical Services, Inc.1989-06-15
KINETIC MODEL 500 (K891756)Kinetic Biomedical Services, Inc.1989-04-19
KINETIC MODEL 1000 (K891757)Kinetic Biomedical Services, Inc.1989-04-19
SMITH & NEPHEW DAYLIGHTER(TM) (K873786)Smith & Nephew, Inc.1987-10-23
CHICK SURIGICAL LIGHT (K860739)Professional Medical Products, Inc.1986-03-28
AMSCO POLARIS SL (K854922)Amsco Co.1986-01-24
CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT (K820681)Sybron Corp.1982-04-15
9100 DAYSTAR AND 9110 ORBITER PACKAGE (K781887)Castle Co.1978-12-12
DAYSTAR SELECTRA & SELECTRA/ORBITER (K780666)Castle Co.1978-04-27
DAYSTAR SURG. LIGHT 9100 & ORBITER 9110 (K771865)Castle Co.1977-11-28

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