ClearanceBrief
Product code REK ยท Class N

Research Laser

0510(k)s in 12 months (0 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
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Top companies in REK

Company510(k)sRecalls
Zeiss, Carl Inc02
89 NORTH01
Energetiq Technology Inc01
Ithera Medical Gmbh01
DateFirm and productCodeLinked 510(k)
Feb 7, 2025Ithera Medical Gmbh
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using c
Open, Classified
REKNone listed
Jan 31, 202089 NORTH
LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
Terminated
REKNone listed
Sep 27, 2019Energetiq Technology Inc
EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.
Open, Classified
REKNone listed
Feb 29, 2012Zeiss, Carl Inc
DirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an extension unit for Axio Observer that is used for microscopic analyses of dynamic processes within living cells. Th
Terminated
REKNone listed
Feb 29, 2012Zeiss, Carl Inc
Carl Zeiss Microimaging Laser-TIRF (Total Internal Reflection Fluorescence) Imaging System is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use.
Terminated
REKNone listed

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