Product code FTD
- Device name
- Lamp, Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4580
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133425 | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT | Engineered Medical Solutions Co., LLC | 2013-12-05 |
| K130513 | VOLISTA 400; VOLISTA 600 | Maquet S.A.S. | 2013-05-08 |
| K123776 | POLARIS 100/200 | Drager Medical GmbH | 2013-03-08 |
| K111020 | ATRICURE DISSECTOR | AtriCure, Inc. | 2011-06-09 |
| K100234 | HM-LAMP II | Hillusa, Inc. | 2010-07-08 |
| K100884 | STRYKER KNIFELIGHT | Howmedica Osteonics Corp. | 2010-06-25 |
| K071180 | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 | Engineered Medical Solutions Co., LLC | 2007-06-20 |
| K053364 | HALUX IRIS EXAMINATION AND SURGICAL LAMP | Waldmann Lighting | 2006-02-23 |
| K041681 | ATRICURE DISSECTOR | AtriCure, Inc. | 2004-07-01 |
| K013242 | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM | STERIS Corporation | 2001-12-13 |
| K010724 | SOLA 700,SOLA 500, SOLA 300 | Drager Medizintechnik GmbH | 2001-06-07 |
| K003423 | ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 | St. Francis Medical Equipment Co., Ltd. | 2001-02-22 |
| K981717 | STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR | Stryker Instruments | 1998-06-30 |
| K961122 | STRYKER KNIFELIGHT | Stryker Instruments | 1996-08-22 |
| K954263 | XE-LITE | Ophthalmic Technologies, Inc. | 1995-10-18 |
| K942553 | GENESIS | Burton Medical Products Corp. | 1994-06-23 |
| K931675 | MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS | Medline Industries, Inc. | 1994-02-22 |
| K932451 | HANAULUX 2005 SURGICAL LIGHT | Heraeus Instruments GmbH | 1993-11-12 |
| K930897 | MI-15 EXAM SURGICAL LIGHT | Medical Illumination, Inc. | 1993-06-25 |
| K895715 | HANAULUX(R) 2000 | W.C. Heraeus GmbH | 1989-10-13 |
| K882613 | ALM SURGICAL LAMPS | Alm Surgical Equipment, Inc. | 1988-07-18 |
| K860088 | PL EXAM LIGHT | Burton Medical Products Corp. | 1986-01-24 |
| K841360 | MINOR SURGICAL LIGHT MODEL 180 | American Sterilizer Co. | 1984-04-24 |
| K823360 | SURGICAL LIGHT | Amsco Co. | 1982-12-03 |
| K811728 | CASTLE & RITTER MINOR SURG. & EXAM LT | Sybron Corp. | 1981-07-20 |
| K801353 | PARKE-DAVIS SURGICAL LIGHT | Warner-Lambert Co. | 1980-06-30 |
| K770861 | SURGICAL COLDLIGHT, AX8 | Affiliated Hospital Products, Inc. | 1977-06-17 |
| K770568 | SURGICAL ILLUMINATOR (SIL) | Fiber Optics Engineering, Inc. | 1977-04-14 |
| K770567 | LIGHT, EXAMINATION, MEDICAL (MEL) | Fiber Optics Engineering, Inc. | 1977-04-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10194665008857 | A-dec | A-DEC, INC. | 2026-05-07 |
| 08881300212001 | KLARO In Vivo Surgical Lighting | VIVO SURGICAL PRIVATE LIMITED | 2023-03-13 |
| M678SLS0 | Sunoptic Technologies | SUNOPTIC TECHNOLOGIES LLC | 2018-06-27 |
| M678ROVER0 | Sunoptic Technologies | SUNOPTIC TECHNOLOGIES LLC | 2017-05-09 |
| M575CPS30 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5759X3GS10 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5759X3GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5758X4GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5758X4GS10 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5754X4GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M575CPS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5754X3GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M57549X3GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M57548X4GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5751X3M0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5759X3M0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5759X3GSW0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M575HND0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M575PWC0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5751X3SFM0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5758X4M0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5758X4GSW0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5754X4M0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5754X4GSW0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5754X3M0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5754X3GSW0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5753X3W0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5753X3M0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5752X3W0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5751X3SFT0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |