Navigation Links
Lumenis Receives 510K Clearance for the PolyScope Disposable Flexible Endoscope
Date:10/27/2009

SANTA CLARA, Calif., Oct. 27 /PRNewswire/ -- Lumenis Ltd., a global developer, manufacturer and seller of laser, light-based and radiofrequency devices for surgical, aesthetic, and ophthalmic applications, announced that on September 30th, 2009 the FDA issued a 510K to Lumenis stating that the PolyScope Flexible Endoscope can now be sold in the United States.

Under this 510K, the PolyScope is indicated in flexible endoscopic procedures for diagnostic and therapeutic applications where flexible endoscopes are standard of care including:

  • Urology, including procedures involving the bladder, ureter, renal pelvis and kidney
  • Gastroenterology, including procedures of the Biliary system involving the hepatic and pancreatic ducts

The PolyScope is an evolution in flexible scope design incorporating a truly disposable endoscopic catheter system with a reusable 10,000 pixel fiber optic. This unique concept solves many of the drawbacks encountered with the use of reusable flexible scopes such as costly and frequent repairs. In addition to the expense, broken scopes create inefficiencies in case load management and staff time needed to complete the logistics of repair and replacement. Scope reprocessing and the potential for contamination is also an issue that is substantially improved with the disposable PolyScope system.

"The clearance of the PolyScope is a significant strategic milestone for the Lumenis Surgical Division," said Dov Ofer, Lumenis' President and CEO. "A strategic focus in the growth of our surgical business has been to build on our core competency in surgical laser systems by adding disposable product lines that complement our current medical applications. This initial clearance for the PolyScope further advances our leadership position in Urology where stones, tumors and strictures are treated through flexible endoscopes using our VersaPulse® holmium lasers and SlimLine(TM) fib
'/>"/>

SOURCE Lumenis Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Lumenis Introduces Advanced Retinal Laser Delivery Technology at the 2009 American Academy of Ophthalmology Annual Meeting in San Francisco, California, USA
2. Lumenis(R) Introduces AcuPulse(TM) for Fractional Laser Treatments
3. Dr. Mark Popovsky Receives Prominent Award for Leadership in Transfusion Medicine
4. Pharmalink AB Receives Patent for Nefecon(R) Principle
5. Solos Endoscopy, Inc. Receives Additional Purchase Orders from National Cancer Institute and National Institute of Health for its MammoView(TM) Product Line
6. Ikaria Receives Award for Excellence by New Jersey Business & Industry Association
7. NASCSA Receives $200,000 Grant From Purdue Pharma L.P. to Support State Prescription Drug Monitoring Programs
8. Jennerex, Inc. Receives EMEA Orphan Drug Designation for JX-594 for the Treatment of Hepatocellular Carcinoma
9. Talecris Biotherapeutics Receives FDA Approval for PROLASTIN(R)-C
10. Solos Endoscopy, Inc. Receives Multiple Purchase Orders for its MammoView(TM) Product Line
11. WorldHeart Receives IRB Approval at First Center in the Levacor(TM) VAD BTT Clinical Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)... July 28, 2014  Air Products (NYSE: ... medical oxygen is vital to any healthcare facility. This ... not only improve the efficiency of its oxygen supply ... highlight these systems—including systems for emergency oxygen supply ... August 4-5 at the 51 st ASHE ...
(Date:7/28/2014)... 28, 2014 Southern Research Institute today ... President and CEO of Southern Research Institute, has ... (CRS) for the 2014-2015 term.  The inauguration took ... 12 in Chicago with ... The Controlled Release Society is an international, ...
(Date:7/28/2014)... WELLINGTON, New Zealand , July 28, 2014 ... Institute in Sweden has ... across multiple vendor platforms and has associated volumetrically ... Published in Cancer Epidemiology, Biomarkers & Prevention ... volumetric mammographic density: a tool for widespread breast ...
Breaking Medicine Technology:Air Products Highlights Its Medical Oxygen Supply Systems for Emergency Oxygen Supply and Reduced Oxygen Loss at ASHE 2Air Products Highlights Its Medical Oxygen Supply Systems for Emergency Oxygen Supply and Reduced Oxygen Loss at ASHE 3Arthur J. Tipton, Ph.D., Named President of Controlled Release Society 2Arthur J. Tipton, Ph.D., Named President of Controlled Release Society 3Karolinska Study Published in Cancer Epidemiology, Biomarkers & Prevention Validates Strong Agreement for VolparaDensity across Mammography Systems from Multiple Manufacturers 2Karolinska Study Published in Cancer Epidemiology, Biomarkers & Prevention Validates Strong Agreement for VolparaDensity across Mammography Systems from Multiple Manufacturers 3Karolinska Study Published in Cancer Epidemiology, Biomarkers & Prevention Validates Strong Agreement for VolparaDensity across Mammography Systems from Multiple Manufacturers 4
... Cardinal Health today announced its board of directors has approved a ... will join the company,s board of directors. At ... per share, payable on Oct. 15 to shareholders of record on ... for Cardinal Health. The board of directors also ...
... The National Pharmaceutical Council (NPC) today welcomed global specialty ... Jeffrey M. Jonas, senior vice president, specialty pharma R&D, ... of directors. "The last few years ... has left many important questions unresolved.  For the pharmaceutical ...
Cached Medicine Technology:Cardinal Health Board of Directors Approves Cash Dividend, Elects David P. King as Director 2Cardinal Health Board of Directors Approves Cash Dividend, Elects David P. King as Director 3National Pharmaceutical Council Welcomes Shire as Its Newest Member 2
(Date:7/28/2014)... A lush green lawn offers the perfect setting for backyard ... heat, lack of rain, foot traffic, and insects can often ... Grounds Guys recommends these suggestions for nurturing your summer lawn: ... and set the height on the lawn mower about one ... heat and allows roots to retain water and grow more ...
(Date:7/28/2014)... 28, 2014 UHY LLP, a member ... edition of UHY International Business – Issue 29. This ... on the most current business challenges and key issues ... 29 covers the following topics:, , ... will thrive over the next five years? Where are ...
(Date:7/28/2014)... July 28, 2014 Dawn Echols’ ... sales, finance, and music. This experience has honed ... direction of psychology. Her professional counseling ( http://dawningphoenix.com ... court-ordered treatment for offenders in domestic violence. ... Phoenix, LLC, she enjoys counseling individuals and groups ...
(Date:7/28/2014)... version of a surgical procedure to treat severe chronic ... 90 percent of the time in patients treated at ... Division of Plastic and Reconstructive Surgery report that more ... procedure all of whom had headaches associated with ... a year later. The team,s paper has received ...
(Date:7/28/2014)... 28, 2014 Shofner Vision Center ... June . Renowned LASIK and Cataract Surgeon, Dr. ... significant funds and public awareness for local not-for-profit ... personnel and their families. “This was our 2nd ... nearly $5,000 to a variety of local not-for-profit ...
Breaking Medicine News(10 mins):Health News:Nurturing Lawns in the Summer Heat: The Grounds Guys® Offers Tips on Caring for Lawns This Summer 2Health News:Uhy International Business Issue 29 Now Available 2Health News:Uhy International Business Issue 29 Now Available 3Health News:Dawn M. Echols, M.S., LPC of Dawning Phoenix Speaks at Newly Formed Task Force 2Health News:Non-endoscopic migraine surgery provides significant symptom relief 2Health News:Shofner Vision Center’s “Operation Military June” Provided Funds For Local Not-For-Profit Organizations Supporting Military And Their Families 2Health News:Shofner Vision Center’s “Operation Military June” Provided Funds For Local Not-For-Profit Organizations Supporting Military And Their Families 3
... Archives of Internal Medicine says that drinking two cups of ... 46 percent. // ,Researchers from the Karolinska ... of 40 and 76 during 1987 to 2004. They found ... this time. When the study started two-thirds of the participants ...
... good sleep help elderly women maintain a destructive protein ... is connected to health problems like Alzheimer's, heart disease, ... Interleukin-6 (IL-6) which runs in the blood stream rises ... damaging protein sank in women who managed to sleep ...
... and amoxicillin when it comes to treating ailments like ... effective. Doctors, who reviewed the treatment given to // ... the newer drugs is more effective than the traditional ... ,Pediatricians at the University of Rochester Medical Center found ...
... studied the blood pressure (BP) and eating habits of 4,304 people ... 18 years and 30 years. An inverse connection was // seen ... grain, and milk, when in comparison to low plant food intake. ... and 36% by the consumption of the second and fifth quintiles. ...
... Canada has announced a ban on the anti-inflammatory drug Bextra, ... from the drug were outweighed by the cardiovascular risks, including ... to an expert safety panel. ,The drug ... even prove to be fatal. Pfizer had earlier withdrawn the ...
... is under threat from a drinking problem. This result is ... for Addictions Research of B.C. compared drinking patterns of the ... on the Canadian Addiction Survey done in 2004. ,The ... guidelines for alcohol consumption and 53 per cent were above ...
Cached Medicine News:Health News:Penicillin To Pave Way For New Antibiotics 2
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: