Lumenis Receives Clearance to Market Lumenis One(TM) in Kore

Posting of FDA 510(k) Approval Documents that are part of the public record on the FDA's Website. You can go to this link and review 510(k) appoval summaries for all medical devices going back to 1999:

http://www.fda.gov/MedicalDevices/Produ ... 242632.htm

Lumenis Receives Clearance to Market Lumenis One(TM) in Kore

PostPosted by hopeful19 » Sun Dec 18, 2011 4:26 am

Lumenis Receives Clearance to Market Lumenis One(TM) in Korea and Taiwan.

Dated 2006

Strengthens Leadership Position in Asian Aesthetic Market

YOKNEAM, Israel, Jan. 10 /PRNewswire-FirstCall/ -- Lumenis(R) Ltd. (LUME.PK), a global developer, manufacturer and seller of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications, announced today that it has received approval to market its Lumenis One(TM) aesthetic system from the Korean FDA (Food and Drug Administration) and an import license from the Taiwan Ministry of Health.

"We are pleased that the clinical efficacy and product safety of our flagship Lumenis One aesthetic system has once again been stringently reviewed and publicly validated," commented Avner Raz, Lumenis' President and Chief Executive Officer. "The launch of our popular Lumenis One into Korea and Taiwan will further strengthen Lumenis' position as the leading aesthetic system supplier in the Asia region. Furthermore, recent industry estimates suggest the combined aesthetic laser and light device market in Korea and Taiwan is over $38M and growing rapidly, with skin treatments driving the market. Our Lumenis One provides practitioners leading edge technology to address the vast majority of their aesthetic treatment needs in one sophisticated platform -- better for their patients and their practice," continued Mr. Raz.

Mr. Qiying Zhai, Lumenis' Vice President for China and Asia Pacific, further commented, "We are confident that Lumenis One will be as well received in Korea and Taiwan as it has been elsewhere in the region, where physicians report very safe and effective treatments on Asian skin, and demand for Lumenis One is growing steadily."

About Lumenis One(TM)

Lumenis One is a multi-technology, multi-application and upgradeable platform designed for comprehensive aesthetic treatments. The Lumenis One platform provides several world-class technologies in one modular and customizable system -- IPL(R) (Intense Pulse Light) for skin rejuvenation and treating vascular and pigmented lesions, LightSheer(R) diode laser for hair removal, Multi-Spot(TM) Nd:YAG laser for deeper vascular lesions and leg veins, as well as the recently introduced Aluma(TM) for predictable and virtually pain-free skin renewal. The system's key features include Optimal Pulse Technology (OPT(TM)), numerous presets, easy custom settings and an intuitive touch-screen software interface. These enable Lumenis One to provide increased patient comfort, faster treatments and easily tracked patient information.

About Lumenis

Lumenis is a global developer, manufacturer and seller of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications. The Company offers a wide range of products along with extensive product support systems including training, education and service. Lumenis invests heavily in research and development to maintain and enhance its leading industry position. The Company holds numerous patents worldwide on its technologies.
Investors:
Lauri Hanover 1-866-232-6803
972-4-959-9122




The statements in this press release that are not historical facts are forward-looking statements which are subject to risks and uncertainties. The Company's actual results could differ materially from those anticipated in the forward looking statements based on a variety of factors, including, among others: uncertainties with respect to market acceptance of the Company's products, the implementation and outcome of our Turnaround Plan, obtaining regulatory approvals for new products or for the sale of existing products in new markets and enforcement of intellectual property rights; risks associated with competition and competitive pricing pressures, economic conditions generally, the Company's international operations and the Company's ability to integrate its operations with those of acquired businesses; the outcome of the Securities and Exchange Commission investigation (including the Wells Notice recently received in which the staff indicated its intention to recommend that a civil proceeding be brought seeking, among other things, injunctive relief and civil monetary penalties) and several securities class action lawsuits to which the Company is subject and the outcome of the investigation conducted by the Audit Committee; uncertainties relating to the Company's continuing liquidity; and other risks detailed from time to time in the reports filed by Lumenis with the SEC, including its annual report on Form 10-K and quarterly reports on Form 10-Q.

CONTACT: Investors - Lauri Hanover, +1-1-866-232-6803, +1-972-4-959-9122
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
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