Atlas FDA

GCT

47 FDA 510(k) clearances · Product code

78 daysmedian time to decision
218 days90th percentile
47clearances measured

FDA profile

Official device name
Light Source, Endoscope, Xenon Arc
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 149 · 2022: 158 · 2023: 200 · 2024: 296 · 2025: 349 · 2026: 380
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ALPHAXENON LIGHT 180 W AND 300 W (K093125)Gimmi GmbH2010-01-27
XENON-100 SCB LIGHT SOURCE, MODEL 20132620 (K082925)KARL STORZ Endoscopy-America, Inc.2008-12-18
CONMED LINVATEC 300W XENON LIGHT SOURCE (K070376)Conmed Linvatec2007-08-20
VIADUCT MINISCOPE AND ACCESSORIES (K040949)Acueity, Inc.2004-05-07
KSEA MEDI PACK (K022490)KARL STORZ Endoscopy-America, Inc.2003-09-29
LINVATEC 300W XENON LIGHT SOURCE (K031994)Linvatec Corp.2003-08-21
ENDOSCOPIC LIGHT SOURCE XL180/L3 (K023468)World of Medicine Lemke GmbH2003-01-14
ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 (K021717)World of Medicine Lemke GmbH2002-08-20
ENDOSCOPIC LIGHT SOURCE XL202/L3 (K020889)World of Medicine Lemke GmbH2002-06-05
DAYLITE XENON LIGHT SOURCES (K013880)Designs For Vision, Inc.2001-12-07
LUMENON XENON LIGHT SOURCE (K992050)Walter Lorenz Surgical, Inc.1999-09-14
XENON LIGHT SOURCE PES 1 (K992540)Laser Optik Systeme GmbH & Co. KG1999-09-14
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011 (K983628)Richard Wolf Medical Instruments Corp.1998-12-11
XENON LIGHT SOURCE, MODELS LS6180, LS6035 (K982962)Contec Medical Vision, Ltd.1998-09-23
XENON LIGHT SOURCE MODEL LS6000 (K981804)Contec Medical Vision, Ltd.1998-07-24
WELCH ALLYN XENON 300 LIGHT SOURCE (K980281)Welch Allyn, Inc.1998-02-27
COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM (K971057)Cogent Light Technologies, Inc.1997-03-28
WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 (K963227)Products For Medicine1996-10-23
ENDOBEAM (K963044)Corin USA1996-09-20
XENON LIGHTSOURCE (K962365)Dsp Worldwide1996-07-18
XENON NOPPVA (K954561)KARL STORZ Endoscopy-America, Inc.1995-10-19
XLS-300 XENON LIGHT SOURCE (K953924)Specialties of Surgery1995-09-21
COLD LIGHT SOURCE LOS XL-A 100 (K952028)Laser-Optik-Systeme GmbH & Co. KG1995-07-27
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (K952563)The Tulip Mfg. Co.1995-07-25
XENON LIGHT SOURCE MODEL 5121 (K952696)Richard Wolf Medical Instruments Corp.1995-07-25
XENON LIGHT SOURCE (K951971)Envision Medical Corp.1995-05-24
ACCU-BEAM 300W XENON LIGHT SOURCE (K951895)Tti Medical1995-05-24
MODEL 5135 AUTO LP/FLASH (K944607)Richard Wolf Medical Instruments Corp.1994-12-13
MODEL 5151 (K944821)Richard Wolf Medical Instruments Corp.1994-11-14
KARL STORZ XENON LIGHT SOURCE MODEL 201320-20 (K934559)KARL STORZ Endoscopy-America, Inc.1994-04-22
LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM (K940270)Welch Allyn, Inc.1994-04-20
ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES (K936198)Carl Zeiss, Inc.1994-04-06
COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE (K933405)Cogent Light Technologies, Inc.1994-02-18
COOL LIGHT 300 (K935423)Endosurgical Development Corp.1994-01-26
ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES (K933868)Angiolaz, Inc.1993-11-10
VERRES NEEDLE (K932281)Surgeon Surgical Instrumentation, Inc.1993-08-06
XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 (K924897)Medical Devices, Inc.1993-07-06
PENTAX XENON LIGHT SOURCE (K921315)Pentax Precision Instrument Corp.1993-06-25
SYSTEM 3000 XENON VIDEOLAP LIGHT (K923210)Cabot Medical Corp.1992-10-05
XENON LIGHT SOURCE AND ACCESSORIES (K921390)Coopervision Surgical1992-07-27
MARLOW VERRES NEEDLES (K913586)Marlo Surgical Technology1991-10-08
OLYMOUS XLS XENON LIGHT SOURCE (K912354)Perkinelmer Optoelectronics1991-08-16
ENDOSCOPIC LIGHT SOURCE (K911492)United States Endoscopy Group, Inc.1991-08-14
ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE (K905282)Frantz Medical Development, Ltd.1991-03-19
MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE (K905124)Red Wing Imaging, Inc.1991-01-25
THE KEYMED HI-LIGHT 250 LIGHT SOURCE (K864801)Keymed, Inc.1986-12-24
PENTEX UPPER G.I. SCOPE MODEL FG-28A (K792215)Pentax Precision Instrument Corp.1979-12-10

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