Atlas FDA

FCW

31 FDA 510(k) clearances · Product code

59 daysmedian time to decision
109 days90th percentile
31clearances measured

FDA profile

Official device name
Light Source, Fiberoptic, Routine
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 147 · 2022: 166 · 2023: 179 · 2024: 179 · 2025: 141 · 2026: 94
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
NOVAPROBE LED LIGHT SOURCE (K131226)Novaprobe Incorporated2014-07-24
POWER LED 175 (K123956)KARL STORZ Endoscopy-America, Inc.2013-01-25
OVS1 VIDEO SYSTEM (K123359)Olive Medical Corp.2012-12-19
ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (K121724)Richard Wolf Medical Instruments Corp.2012-09-20
LED LIGHT SOURCE (K093792)Sunoptic Technologies, LLC2010-03-18
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C (K091968)KARL STORZ Endoscopy-America, Inc.2009-09-14
STRYKER LED LIGHTSOURCE (K082813)Stryker Corp.2008-12-19
LUXTEC MLX LIGHT SOURCE (K081477)Integra Luxtec, Inc.2008-06-18
ACUEITY MEDICAL LIGHT SOURCE (K032430)Acueity, Inc.2003-09-05
METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (K012265)Circon Video2001-10-17
VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE (K000229)Videolabs, Inc.2000-03-21
COLDLIGHTSOURCE PL3000 (K993300)Fiber Imaging Technologies, Inc.1999-11-05
50 W METAL HALIDE ILLUMINATOR, VES 0501. (K992447)Angiolaz, Inc.1999-10-20
INTEGRATED VISUALIZATION SYSTEM (K970598)Urohealth, Inc.1997-03-12
PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 (K964586)Iba/Griffith1997-01-17
ENDOSPOT (K963043)Corin USA1996-09-20
WELCH ALLYN HI - LUX ILLUMINATOR (K951647)Welch Allyn, Inc.1995-05-17
CHAKOFF ENDOSCOPY (K945420)Stephen Chakoff, Inc.1994-12-08
HMT ENDOSCREEN, MODEL ESC 501 (K942155)Servicetrends, Inc.1994-07-01
AUTO SUTURE DISPOSABLE LIGHT CABLE (K934531)United States Surgical, A Division of Tyco Healthc1994-05-18
CUDA PRODUCTS CORP. LIGHTSOURCES (K933369)Cuda Products Co.1994-01-03
STORZ S6000 LIGHT SOURCE (K905376)Storz Instrument Co.1991-01-23
ENDOSCOPIC LIGHT SOURCE 250 ENDO (K903790)Orlux Engineering and Instrumentation1990-12-07
LUXTEC ACO SERIES 4000 LIGHT SOURCE (K890716)Luxtec Corp.1989-04-26
LUXTEC LIGHT SOURCES (K864385)Luxtec Corp.1987-01-13
WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS (K852951)Welch Allyn, Inc.1985-08-27
R.L. MEDICAL TWIN LIGHT SOURCE (K842609)Tridak Division of Indicon, Inc.1984-08-09
PEDIATRIC ILLUMINATING URETERAL (K832807)Van-Tec, Inc.1983-10-19
PENTAX LH-150F LIGHT SOURCE (K771739)Pilling Co.1977-09-30
ADAPTER, FIBER OPTICS HEADLIGHT (K760647)Pilling Co.1976-12-06
FLOORSTAND, FIBER OPTIC LIGHT SOURCE (K760176)V. Mueller O.V. Baxter Healthcare Corp.1976-08-30

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