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

0

GOOD

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:6/18/2013)... -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX ... VPII Escrow Corp., a newly formed wholly owned Canadian ... approximately $3.2 billion aggregate principal amount of senior unsecured ... 2021 and in 2023, with final tranching determined at ... net proceeds from the offering, together with proceeds from ...
(Date:6/18/2013)... HILL, Conn. , June 18, 2013 /PRNewswire/ ... past clients of Alliance Seating and Mobility, a ... unable to access timely repair. This appears to ... a dramatic reduction of field service employees.  ... Unfortunately a great many of these clients are ...
(Date:6/18/2013)... LEANDRO, Calif. , June 18, 2013  Cataracts ...  According to the American Association of Ophthalmology, aging is ... a clouding of the eye,s natural lens. 22 million ... 2020, as Baby Boomers continue to age, that number ... high tech world of iPhones, iPads, smart-phones and computers, ...
Breaking Medicine Technology:Valeant Pharmaceuticals Announces Launch Of Private Offering Of Senior Notes 2Valeant Pharmaceuticals Announces Launch Of Private Offering Of Senior Notes 3New Vision Hope For Millions Undergoing Cataract Surgery 2New Vision Hope For Millions Undergoing Cataract Surgery 3
... SILVER SPRING, Md., Aug. 3, 2011 The U.S. ... specific treatment for a scorpion sting by Centruroides ... (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO ) Venomous scorpions ... stings occur most frequently in infants and children, and ...
... NEW YORK, Aug. 2, 2011 A new national survey ... may put them at risk of contracting meningococcal meningitis, a ... take the life of an otherwise healthy child in just ... in collaboration with Sanofi Pasteur, conducted the survey as part ...
Cached Medicine Technology:FDA Approves the First Specific Treatment for Scorpion Stings 2National Survey Shows: Vast Majority of Preteens and Teens Engage in Activities That May Put Them at Risk for Contracting Meningitis 2National Survey Shows: Vast Majority of Preteens and Teens Engage in Activities That May Put Them at Risk for Contracting Meningitis 3National Survey Shows: Vast Majority of Preteens and Teens Engage in Activities That May Put Them at Risk for Contracting Meningitis 4
(Date:6/19/2013)... 2013 PREFERRED Therapy Providers, Inc. (PREFERRED) ... to offer a new Medicare Advantage Plan for ... Yavapai and Mohave, Arizona counties. The agreement takes effect ... January 1, 2013 and Maricopa and Pima counties will ... the parent company of WellCare of Arizona has Medicare ...
(Date:6/19/2013)... DiscountFurnaceFilter.com, the number one solution for homeowner’s ... Compressor Saver kit at an exceptional price. The 5-2-1 Compressor ... air conditioning unit during start up, saving wear and tear ... unit burn out. , The 5-2-1 Compressor Saver ... uses less power to start and drastically reduces the rush ...
(Date:6/19/2013)... Brightree LLC , the leading provider ... the post-acute care industry, has been ranked for the first ... Informatics 100 (HCI 100) list. This prestigious list features ... terms of revenue during the last fiscal year. Since 2005, ... annually, and the company has built its organization to more ...
(Date:6/19/2013)... CA (PRWEB) June 19, 2013 Alternatives, ... permits some patients to quit using drugs while allowing ... Adi Jaffe, the founders of Alternatives, believe that abstinence-only ... before they enter treatment and that this approach hurts ... million people in the United States need treatment for ...
(Date:6/19/2013)... Guests at the Residence Inn Scottsdale Paradise Valley ... don’t go to bed or rise early thanks to a ... , Crafty travelers will have a little extra change ... Scottsdale Paradise Valley hotel’s Book Early and Save Up ... advance notice, guests can enjoy the year-round Scottsdale sunshine in ...
Breaking Medicine News(10 mins):Health News:PREFERRED Therapy Providers, Inc. and WellCare of Arizona Finalize Their Agreement to Offer Medicare Advantage Plan to PREFERRED's Arizona Provider Network 2Health News:Brightree Debuts on List of Top 100 Healthcare Technology Companies 2Health News:Brightree Debuts on List of Top 100 Healthcare Technology Companies 3Health News:Top L.A. Addiction Experts Assert That an Abstinence-Only Approach to Addiction Keeps 85% of Addicts From Seeking Treatment 2Health News:Top L.A. Addiction Experts Assert That an Abstinence-Only Approach to Addiction Keeps 85% of Addicts From Seeking Treatment 3Health News:Plan Ahead and Save Big With New Deal From Residence Inn Scottsdale Paradise Valley 2Health News:Plan Ahead and Save Big With New Deal From Residence Inn Scottsdale Paradise Valley 3Health News:Plan Ahead and Save Big With New Deal From Residence Inn Scottsdale Paradise Valley 4
... Girls involved in high-impact activities such as running, basketball, gymnastics ... new study finds. Researchers analyzed seven years of data ... States. During that time, 267 (3.9 percent) of the girls ... of osteoporosis or lone bone-mass density had nearly twice the ...
... April 5, 2011 Despite a growing number of ... cropping up everywhere from chic downtown cafes to locations ... in young adults. A new study done by researchers ... increasingly popular pastime, and the results are discouraging. ...
... Research led by Warwick Medical School at the University of ... to treat diabetes and also in women with Polycystic vary ... Endometrial cancer is the most common malignancy of the female ... in the UK and the US. Up to a ...
... fusion for scoliosis using the newest surgical techniques can expect ... a Hospital for Special Surgery study published online ahead of ... . Researchers had thought that the surgery would cause damage ... study showed that this was not the case. "Fusion ...
... Reporter , MONDAY, April 4 (HealthDay News) -- It may be ... factors for heart disease. A new study has ... having a heart attack by working more hours than their peers. ... that employees who regularly worked 11-hour days or longer were 67 ...
... -- Sudden cardiac death kills more young athletes in ... new study. An analysis of news reports, insurance ... (NCAA) revealed that one in 43,770 NCAA athletes suffer ... the University of Washington in Seattle. The investigators ...
Cached Medicine News:Health News:Girls in Some Sports Face Raised Risk of Stress Fractures: Study 2Health News:Hookah use widespread among college students 2Health News:Hookah use widespread among college students 3Health News:Diabetes treatment may also provide protection against endometrial cancer 2Health News:Study shows that modern surgery for scoliosis has good long-term outcomes 2Health News:Study shows that modern surgery for scoliosis has good long-term outcomes 3Health News:Too Many Hours at Work Might Harm the Heart 2Health News:Too Many Hours at Work Might Harm the Heart 3Health News:Sudden Cardiac Death More Common in Young Athletes Than Thought 2
... simple intuitive programming and almost completely noiseless ... personal cycler in the modern laboratory workplace. ... self-adjusting heated lid allows a choice of ... a microplate of 5 x 5 in ...
... temperature cyclers, the gradient block can be set ... to 14 or 22 across the 40- or ... up to 2C between adjacent wells in each ... 12 different annealing temperatures in a single experiment. ...
... Mx3005P instrument and custom filter wheels ... filters. The standard filter set includes: ... ROX/Texas Red (585nm-610nm), Cy5 (635nm-665nm) and ... Mx3005P analysis software, Beacon Designer oligo ...
... is a rapid, real-time thermal cycler used ... By automating much of the testing process, ... it is the fastest, easiest to use, ... market. The SmartCycler delivers highly accurate and ...
Medicine Products: