Product code FSS
- Device name
- Light, Surgical, Floor Standing
- 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 |
|---|---|---|---|
| K091246 | ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) | Trumpf Medizin Systeme GmbH + Co. KG | 2009-09-28 |
| K003489 | NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 | Medical Illumination International, Inc. | 2001-02-02 |
| K984124 | AESCULAP XENON LIGHT SOURCE | Aesculap, Inc. | 1999-02-01 |
| K981962 | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | Cuda Products Co. | 1998-08-18 |
| K981821 | VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR | Angiolaz, Inc. | 1998-07-29 |
| K981469 | CERMAX300 LIGHTSOURCE | Cuda Products Co. | 1998-07-09 |
| K980044 | XENON 300MX | Perkinelmer Optoelectronics | 1998-04-03 |
| K970886 | HANAULUX BLUE 80 HOSPITAL | Heraeus Med GmbH | 1997-04-16 |
| K961971 | Q-5000 | Stryker Endoscopy | 1996-06-28 |
| K961074 | LIGHTSOURCE OR ILLUMINATOR | Cuda Products Co. | 1996-04-30 |
| K930711 | TRI*STAR | Light Technology Systems | 1993-07-30 |
| K910942 | AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT | Mdt Biologic Co. | 1991-06-11 |
| K895950 | MODEL FEL5100 FLOOR LIGHT | F.W. Lang Co. | 1989-10-31 |
| K893813 | FLOOR STANDING, OPERATING AND EXAMINING LIGHT | Astralite Corp. | 1989-07-14 |
| K891758 | KINETIC MODEL 132 | Kinetic Biomedical Services, Inc. | 1989-04-19 |
| K891759 | KINETIC MODEL 330 | Kinetic Biomedical Services, Inc. | 1989-04-19 |
| K882333 | FLOOR LIGHT | Commercial Products & Engineering Co. | 1988-06-23 |
| K880540 | LIGHT, SURGICAL, FLOOR STANDING | Ferguson Medical | 1988-02-24 |
| K880198 | GEMINI SURGICAL LIGHT | American Sterilizer Co. | 1988-02-10 |
| K860020 | MINOR SURGERY LIGHT MODEL 2112 | Adel Medical , Ltd. | 1986-01-24 |
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| M678XLS0 | Sunoptic Technologies | SUNOPTIC TECHNOLOGIES LLC | 2017-09-29 |
| M57548X4GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5758X4GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5758X4GS10 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5759X3GS10 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5754X4GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5754X4GS10 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5759X3GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5754X3GS10 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5751X3SFM0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5759X3M0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M575GHC0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M575JZB0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M575PWC0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M575SBR0 | 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 |
| M5754X3M0 | 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 |
| M5752X3M0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5751X3W0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5751X3SFT0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| 10841736100025 | Aurora Surgical Light Series | SKYTRON LLC | 2016-09-19 |
| 10841736100032 | Aurora Surgical Light Series | SKYTRON LLC | 2016-09-19 |
| 10841736100070 | Aurora Surgical Light Series | SKYTRON LLC | 2016-09-19 |
| 10841736100124 | Nautilus Surgical Light Series | SKYTRON LLC | 2016-09-19 |