FDA Product Code
FDA Product Code FSY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4580
510(k) Clearances — 74 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K142984 | Leo Minor | Sunnex, Inc. | 2014-10-29 | Traditional | PDF ↗ |
| K142076 | CLAVEGUARD FREEDOM SURGICAL LIGHT | Dickson & Dickson Healthcare (Us), Inc. | 2014-09-30 | Traditional | PDF ↗ |
| K140812 | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | Medical Illumination International, Inc. | 2014-08-07 | Traditional | PDF ↗ |
| K132551 | ZF 720 | Umbel Corporation | 2014-06-30 | Traditional | PDF ↗ |
| K140930 | VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES | Convida Healthcare & Systems Corporation | 2014-06-09 | Traditional | PDF ↗ |
| K140460 | MACH LED 2SC | Dr. Mach GmbH & Co. KG | 2014-04-03 | Special | PDF ↗ |
| K140461 | MACH LED 2MC | Dr. Mach GmbH & Co. KG | 2014-04-03 | Special | PDF ↗ |
| K132747 | VISUM BLADE LED SURGICAL LIGHTING SYSTEM | Stryker Communications | 2013-12-30 | Traditional | PDF ↗ |
| K132307 | VIDA LED SURGICAL LIGHTING SYSTEM | Convida Healthcare & Systems Corporation | 2013-11-05 | Traditional | PDF ↗ |
| K131893 | AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS | Ajw Technology Consultants, Inc. | 2013-10-30 | Traditional | PDF ↗ |
| K122875 | ORICARE L2700 | Oricare, Inc. | 2012-12-18 | Traditional | PDF ↗ |
| K120392 | CHROMOPHARE F 628 AND F 528 | Berchtold GmbH & Co. KG | 2012-02-16 | Traditional | PDF ↗ |
| K102758 | TRULIGHT 5520 AND TRULIGHT 5320 | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2010-10-26 | Traditional | PDF ↗ |
| K101537 | AIM 200, MAJOR SURGICAL LIGHT | Burton Medical Products Corp. | 2010-09-30 | Traditional | PDF ↗ |
| 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 | Huot Instruments, LLC | 2010-07-20 | Traditional | PDF ↗ |
| K093010 | MACH LED MC | Dr. Mach GmbH & Co. KG | 2010-04-01 | Traditional | PDF ↗ |
| K093009 | MACH LED SC | Dr. Mach GmbH & Co. KG | 2010-04-01 | Traditional | PDF ↗ |
| K090378 | CHROMOPHARE E 668 | Berchtold GmbH & Co. KG | 2009-02-23 | Traditional | PDF ↗ |
| K083323 | NUVO VERDE LED LIGHTING SYSTEM | Nuvo, Inc. | 2009-01-28 | Abbreviated | PDF ↗ |
| K083066 | CHROMOPHARE E 778 AND E 558 | Berchtold Holding GmbH | 2008-10-30 | Traditional | PDF ↗ |
| K080857 | CHROMOPHARE E-SERIES | Berchtold Holding GmbH | 2008-04-10 | Traditional | PDF ↗ |
| K072072 | HARMONY LED-1 SURGICAL LIGHTING SYSTEM | STERIS Corporation | 2007-10-05 | Traditional | PDF ↗ |
| K071698 | AURORA LED SERIES SURGICAL LIGHTS | Skytron, Div. the Kmw Group, Inc. | 2007-07-06 | Traditional | PDF ↗ |
| K070442 | POWERLED SURGICAL LIGHT SYSTEM | Maquet S.A. | 2007-03-16 | Special | PDF ↗ |
| K063333 | M3 | Mavig GmbH | 2006-11-21 | Traditional | PDF ↗ |
| K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006-06-22 | Traditional | PDF ↗ |
| K060802 | VISUM LED SURGICAL LIGHTING SYSTEM | Stryker Communications Corp. | 2006-04-07 | Traditional | PDF ↗ |
| K042395 | OUTPATIENT III MINOR SURGERY LIGHT | Burton Medical Products Corp. | 2004-12-01 | Traditional | PDF ↗ |
| K042382 | DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD | Med-General Technologies, LLC | 2004-11-30 | Traditional | PDF ↗ |
| K040735 | ALM X'TEN (X10) SURGICAL LIGHT SYSTEM | Alm S.A. | 2004-05-21 | Special | PDF ↗ |
| K040015 | MODIFICATION TO PRISMALIX SURGICAL LIGHT | Alm S.A. | 2004-01-21 | Special | PDF ↗ |
| K031068 | STRYKER VISUM SURGICAL LIGHTING SYSTEM | Stryker Endoscopy | 2003-08-12 | Traditional | PDF ↗ |
| K031979 | CONMED INTEGRATED SYSTEMS NURSES ASSISTANT | Conmed Integrated Systems (Cmis) | 2003-07-25 | Special | PDF ↗ |
| K030906 | AXCEL SURGICAL LIGHT | Alm | 2003-04-23 | Special | PDF ↗ |
| K024132 | CHROMOPHARE X 65 | Berchtold Holding GmbH | 2003-03-21 | Special | PDF ↗ |
| K021585 | STELLAR SERIES SURGICAL LIGHTS WITH HERMES | Skytron, Div. the Kmw Group, Inc. | 2002-11-13 | Traditional | PDF ↗ |
| K011693 | TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 | Trumpf Medical Systems, Inc. | 2001-06-13 | Traditional | PDF ↗ |
| K010716 | VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB | Valmed Corp. | 2001-05-30 | Traditional | PDF ↗ |
| K002463 | STELLAR | Skytron, Div. the Kmw Group, Inc. | 2000-11-08 | Traditional | PDF ↗ |
| K000639 | VISIONARY 2000 | Burton Medical Products Corp. | 2000-05-25 | Traditional | PDF ↗ |
| K993242 | CASTLE SURGICAL LIGHT, MODEL 3000 | Getinge/Castle, Inc. | 1999-11-08 | Traditional | PDF ↗ |
| K992090 | MILLENNIUM GOLD | Skytron, Div. the Kmw Group, Inc. | 1999-09-08 | Traditional | PDF ↗ |
| K990656 | CHROMOPHARE D 530 LDR SURGICAL LIGHT | Berchtold Holding GmbH | 1999-07-20 | Traditional | PDF ↗ |
| K991527 | CHROMOPHARE D500, D530, D650 | Berchtold Holding GmbH | 1999-05-27 | Special | PDF ↗ |
| K984611 | DRAGER SOLA SERIES, MODELS 1000/700/500/300 | Drager Medizintechnik GmbH | 1999-03-29 | Abbreviated | PDF ↗ |
| K982063 | ALM PRISMALIX (PRX) SURGICAL LIGHT | Alm Surgical Equipment, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K981081 | BRIGHTSTAR | Hill-Rom, Inc. | 1998-04-29 | Traditional | PDF ↗ |
| K974084 | GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT | Getinge/Castle, Inc. | 1998-03-03 | Traditional | PDF ↗ |
| K974433 | CHROMOPHARE D 500, CHROMOPHARE D 530 | Berchtold Holding GmbH | 1998-02-20 | Traditional | PDF ↗ |
| K973466 | HANAULUX BLUE 75 AND HANAULUX BLUE 120 | Heraeus Med GmbH | 1997-10-24 | Traditional | PDF ↗ |
| K965130 | CHROMOPHARE | Berchtold Holding GmbH | 1997-07-14 | Traditional | PDF ↗ |
| K963682 | GENIE' SINGLE CEILING AND DOUBLE CEILING | Burton Medical Products Corp. | 1996-11-13 | Traditional | PDF ↗ |
| K961843 | GENIE | Burton Medical Products Corp. | 1996-08-22 | Traditional | PDF ↗ |
| K954169 | HANAULUX BLUE 30 & 80 | Heraeus Med GmbH | 1996-02-01 | Traditional | PDF ↗ |
| K944855 | CHROMOPHARE | Berchtold Holding GmbH | 1994-10-19 | Traditional | PDF ↗ |
| K943288 | AMSCO SQ240 SURGICAL LIGHT | American Sterilizer Co. | 1994-10-17 | Traditional | PDF ↗ |
| K922836 | CHROMOPHARE | Berchtold Holding GmbH | 1992-10-09 | Traditional | PDF ↗ |
| K915285 | SKYTRON INFINITY SERIES SURGICAL LIGHTS | Skytron, Div. the Kmw Group, Inc. | 1992-02-20 | Traditional | PDF ↗ |
| K914076 | MDT/CASTLE 2000 SURGICAL LIGHTS | Mdt Corp., Inc. | 1991-11-13 | Traditional | PDF ↗ |
| K904965 | SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 | Smith & Nephew Equipment Group | 1991-01-16 | Traditional | PDF ↗ |
| K902864 | SURGICAL LIGHTING-CENTRA 450 | Sds Dental, Inc. | 1990-09-10 | Traditional | PDF ↗ |
| K901830 | CHICK III SURGICAL LIGHTING SYSTEM | Chick Medical Products | 1990-05-24 | Traditional | PDF ↗ |
| K900211 | SKYTRON UNIVERSE SERIES SURGICAL LIGHTS | Skytron, Div. the Kmw Group, Inc. | 1990-03-19 | Traditional | PDF ↗ |
| K896674 | AMSCO QUANTUM LIGHT | American Sterilizer Co. | 1990-01-03 | Traditional | PDF ↗ |
| K892808 | KINETIC MODEL 700 | Kinetic Biomedical Services, Inc. | 1989-06-15 | Traditional | PDF ↗ |
| K891757 | KINETIC MODEL 1000 | Kinetic Biomedical Services, Inc. | 1989-04-19 | Traditional | PDF ↗ |
| K891756 | KINETIC MODEL 500 | Kinetic Biomedical Services, Inc. | 1989-04-19 | Traditional | PDF ↗ |
| K873786 | SMITH & NEPHEW DAYLIGHTER(TM) | Smith & Nephew, Inc. | 1987-10-23 | Traditional | PDF ↗ |
| K860739 | CHICK SURIGICAL LIGHT | Professional Medical Products, Inc. | 1986-03-28 | Traditional | PDF ↗ |
| K854922 | AMSCO POLARIS SL | Amsco Co. | 1986-01-24 | Traditional | PDF ↗ |
| K820681 | CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT | Sybron Corp. | 1982-04-15 | Traditional | PDF ↗ |
| K781887 | 9100 DAYSTAR AND 9110 ORBITER PACKAGE | Castle Co. | 1978-12-12 | Traditional | PDF ↗ |
| K780666 | DAYSTAR SELECTRA & SELECTRA/ORBITER | Castle Co. | 1978-04-27 | Traditional | PDF ↗ |
| K771865 | DAYSTAR SURG. LIGHT 9100 & ORBITER 9110 | Castle Co. | 1977-11-28 | Traditional | PDF ↗ |
Product code FSY · Class II · General, Plastic Surgery. Data: openFDA.