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Diabetes / Laser medicine / Blindness / Eye / Pascal Photocoagulator / Macular edema / Diabetic retinopathy / Laser coagulation / Glaucoma / Ophthalmology / Medicine / Health


K1[removed]k) SUMMARY 5.
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Document Date: 2013-12-09 11:45:13

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City

Salt Lake City / /

Company

EMC / The Lumenis Laser Systems / Lumenis Inc. / K130195 Trade / TM The Lumenis Laser Systems / Lurnenis Inc. / Lumnenis Inc. / /

Event

FDA Phase / /

Facility

Grid Photocoagulation Yes Square / Yes Square / New Hampshire Avenue Document Control Center / Branch Retinal Vein Occlusion Yes Square / /

IndustryTerm

Internet address littp /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / MXM Division of Surgical Devices / Center for Devices and Radiological Health / Surgical Devices Office / Mark NIZt-0kerson Mark N. Melkerson Acting Director Division / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Device Evaluation Center for Devices and Radiological Health Enclosure / CDRH's office of Surveillance / /

Person

Jace R. McLane / Laser Characteristics Nidek / Silver Spring / Semi- Pumped Semip LaeyeSolid / /

/

Position

General / conductor / ei conductor / Regulatory Affairs Specialist / /

Product

Federal Food / 2I1CFR / /

ProgrammingLanguage

PASCAL / /

ProvinceOrState

Maryland / Illinois / Utah / /

Region

South Salt / /

Technology

radiation / fundamental scientific technology / Laser System / Laser / Lasers / same fundamental scientific technology / /

URL

www.fda.gov/MedicalDevices/ResotircesforYOLI/Industrv/defILI.htm / www.Iumnenis.comn / www.fda.gov/Medica / www.Iurnenis.con / http /

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