Healthcare Industry News: dental laser
News Release - February 7, 2008
Biolase Announces FDA 510(k) Clearance of Its Waterlase(R) MD Laser System for DermatologyIRVINE, CA--(Healthcare Sales & Marketing Network)--Feb 7, 2008 -- BIOLASE Technology, Inc. (NasdaqGM:BLTI ), the world's leading dental laser company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) allowing it to market a version of its WaterlaseŽ MD Laser System for use in dermatological applications as well as general and plastic surgery.
Jake St. Philip, Chief Executive Officer, said, "Our singular operational focus today is executing in the dental suite and building on the success of our hard- and soft-tissue dental laser franchise. That said, FDA clearances such as we announced today only serve to build on our proprietary intellectual assets and add value that can be monetized through licensing, partnerships and in some cases future product offerings. We are very pleased with the new indications and applaud the scientific and regulatory teams for this accomplishment."
New FDA-cleared indications for the WaterlaseŽ MD Derm device include incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing.
In addition, general surgical use of the device is now allowed for incision, excision, vaporization and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
About BIOLASE Technology, Inc.
BIOLASE Technology, Inc. (http://www.biolase.com), the world's leading dental laser company, develops, manufactures and markets lasers and related products that advance the practice of dentistry and medicine. The Company's products incorporate patented and patent pending technologies designed to provide clinically superior performance with less pain and faster recovery times. BIOLASE's principal products are dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications. Other products under development address ophthalmology and other medical and consumer markets.
This press release may contain forward-looking statements within the meaning of safe harbor provided by the Securities Reform Act of 1995 that are based on the current expectations and estimates by our management. These forward-looking statements can be identified through the use of words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," "may," "will," and variations of these words or similar expressions. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks, uncertainties and other factors which may cause the Company's actual results to differ materially from the statements contained herein, and are described in the Company's reports it files with the Securities and Exchange Commission, including its annual and quarterly reports. No undue reliance should be placed on forward-looking statements. Such information is subject to change, and we undertake no obligation to update such statements.
Source: BIOLASE Technology
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