Atlas FDA

HQB

30 FDA 510(k) clearances · Product code

98 daysmedian time to decision
272 days90th percentile
30clearances measured

FDA profile

Official device name
Photocoagulator And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4690
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 1 · 2001: 1 · 2003: 3 · 2004: 2 · 2005: 5 · 2020: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers (K220263)Vortex Surgical, Inc.2022-11-03
MAXReach Laser Probe (K191846)Vortex Surgical, Inc.2019-12-23
Vitreq disposable laser probes, light fibers and Chandelier (K182646)VitreQ BV2019-05-01
PEREGRINE CURVED ILLUMINATING LASER PROBE (K132614)Peregrine Surgical , Ltd.2013-11-14
23GA CURVED ILLUMINATING LASER PROBE (K122997)Peregrine Surgical , Ltd.2013-06-26
PEREGRINE 23GA CURVED LASER PROBE (K122905)Peregrine Surgical , Ltd.2013-04-30
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE (K113857)Synergetics, Inc.2012-04-23
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA (K110951)Alcon Research, Ltd.2011-10-17
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI (K111493)Nidek Co., Ltd.2011-07-27
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR (K110228)Nidek Incorporated2011-02-23
LC-250 INFRARED LIGHT COAGULATOR (K964380)Nk-Optik America1997-01-22
GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE (K954306)Gamp & Assoc.1995-12-22
GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE (K954308)Gamp & Assoc.1995-12-22
GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE (K954307)Gamp & Assoc.1995-12-22
OPTOSCALPEL I LASER SYSTEM (K923531)Optomed Corp.1993-11-12
THE ENDO OPTIKS MICROPROBE (K924090)Endo Optics, Inc.1993-02-01
ZIESS ENDOPROBE (K922735)Carl Zeiss, Inc.1992-07-09
SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION (K882679)Surgical Laser Technologies, Inc.1988-12-14
SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION (K882441)Surgical Laser Technologies, Inc.1988-09-26
REUSABLE FIBEROPTIC LIGHTPIPE (K881926)Advanced Surgical Products, Inc.1988-06-06
NIDEK AC-2000 LASER SYSTEM (K860011)Nidek, Inc.1986-02-07
SYSTEM 930 ARGON PHOTOCOAGULATOR (K844356)Coherent Medical Group1985-05-16
ARGON/KRYPTON LASER SYSTEM 8500 (K844209)Cooper Lasersonics, Inc.1985-02-06
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS (K844197)Nidek, Inc.1984-12-24
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE (K844198)Nidek, Inc.1984-12-24
ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS (K843966)American Medical Optics1984-11-08
SLIT LAMP ATTACHMENT (K801877)Cavitron Corp.1980-09-16
PHOTOCOAGULATOR LASER (K780345)Cavitron Corp.1978-05-09
LAMP DELIVERY SYS.-PHOTOCOAGULATION (K772213)Varian Assoc., Inc.1977-12-13
PHOTOCOAGULATOR, LOG 3 PORTABLE XENON (K760444)Varian Assoc., Inc.1976-08-26

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