Atlas FDA

FSS

20 FDA 510(k) clearances · Product code

68 daysmedian time to decision
154 days90th percentile
20clearances measured

FDA profile

Official device name
Light, Surgical, Floor Standing
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2010: 3 · 2013: 11 · 2014: 14 · 2015: 10 · 2019: 13 · 2023: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) (K091246)Trumpf Medizin Systeme GmbH + Co. KG2009-09-28
NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 (K003489)Medical Illumination International, Inc.2001-02-02
AESCULAP XENON LIGHT SOURCE (K984124)Aesculap, Inc.1999-02-01
CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE (K981962)Cuda Products Co.1998-08-18
VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR (K981821)Angiolaz, Inc.1998-07-29
CERMAX300 LIGHTSOURCE (K981469)Cuda Products Co.1998-07-09
XENON 300MX (K980044)Perkinelmer Optoelectronics1998-04-03
HANAULUX BLUE 80 HOSPITAL (K970886)Heraeus Med GmbH1997-04-16
Q-5000 (K961971)Stryker Endoscopy1996-06-28
LIGHTSOURCE OR ILLUMINATOR (K961074)Cuda Products Co.1996-04-30
TRI*STAR (K930711)Light Technology Systems1993-07-30
AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT (K910942)Mdt Biologic Co.1991-06-11
MODEL FEL5100 FLOOR LIGHT (K895950)F.W. Lang Co.1989-10-31
FLOOR STANDING, OPERATING AND EXAMINING LIGHT (K893813)Astralite Corp.1989-07-14
KINETIC MODEL 330 (K891759)Kinetic Biomedical Services, Inc.1989-04-19
KINETIC MODEL 132 (K891758)Kinetic Biomedical Services, Inc.1989-04-19
FLOOR LIGHT (K882333)Commercial Products & Engineering Co.1988-06-23
LIGHT, SURGICAL, FLOOR STANDING (K880540)Ferguson Medical1988-02-24
GEMINI SURGICAL LIGHT (K880198)American Sterilizer Co.1988-02-10
MINOR SURGERY LIGHT MODEL 2112 (K860020)Adel Medical , Ltd.1986-01-24

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Every clearance here is in the API, with alerts when new ones post.