Salton Receives FDA Clearance to Market Rejuvenique as a Class II Medical Device for Cosmetic Use.
MT. PROSPECT, Ill.--(BUSINESS WIRE)--Aug. 13, 2001
Salton, Inc. (NYSE NYSE
See: New York Stock Exchange : SFP SFP Small Form-factor Pluggable (optical transceiver module)
SFP Société Française de Physique (French Physics Society; Paris)
Sfp Svenska Folkpartiet (Finnish: Swedish People~s Party) ) today announced that the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. Food & Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) granted clearance to Salton on August 8, 2001 to market its Rejuvenique(R) facial toning Facial toning is a type of cosmetic procedure which promises to alter facial contour and reduce wrinkles, sagging and expression marks in the face by means of increasing muscle tone, increasing facial volume by promoting muscular hypertrophy, and preventing muscle loss due to aging. system directly to consumers. The FDA clearance was received in response to Salton's pre-market notification to the FDA made under section 510(k) of the Federal, Food, Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act
a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration. . The FDA clearance permits Salton to continue to market Rejuvenique(R), which will be marketed as providing the same cosmetic benefits advertised for the system that Salton had been making prior to the Company's receipt of FDA's Warning Letter.
Leonhard Dreimann, Chief Executive Officer of Salton, stated, "We are extremely pleased to have worked collaboratively with FDA to receive FDA's clearance to market Rejuvenique(R) as a class II medical device for cosmetic uses. We are also extremely pleased to be the first device of this kind to be cleared by FDA for home cosmetic and beauty use. In Salton's view, FDA's review of Salton's independent expert safety reports and its subsequent clearance of our Rejuvenique(R) Ultimate Facial Toning System confirms the unique safety of this product, which is intended to cosmetically enhance a user's appearance. In the months ahead, we will work with all of our customers to restore their inventories of Rejuvenique(R) to the levels necessary to meet the public's demand driven by our signature infomercials on the product hosted by celebrity spokesperson Linda Evans
Linda Evans (born Linda Evanstad on November 18, 1942 in Hartford, Connecticut) is a Golden Globe-winning American actress known primarily for her roles on soap operas ."
About Salton, Inc.
Salton, Inc. is a leading domestic designer, marketer and distributor of a broad range of branded, high quality small appliances under well-recognized brand names such as Salton(R), George Foreman(TM), Toastmaster toast·mas·ter
A man who proposes the toasts and introduces the speakers at a banquet.
a person who introduces speakers and proposes toasts at public dinners
Noun 1. (R), Breadman(R), Juiceman(R), Juicelady(R), White-Westinghouse(R), Farberware(R), Melitta(R), Welbilt(R) and Aircore(R). Salton also designs and markets tabletop products, time products, lighting products and personal care and wellness products under brand names such as Block China(R), Atlantis(R) Crystal, Sasaki(R), Calvin Klein(R), Ingraham(R), Timex(R), Westclox(R), Big Ben(R), Spartus(R), Stiffel(R), Ultrasonex(TM), Relaxor(R), Russell Hobbs(R), Carmen Carmen
throws over lover for another. [Fr. Lit.: Carmen; Fr. Opera: Bizet, Carmen, Westerman, 189–190]
See : Faithlessness
the cards repeatedly spell her death. [Fr. (R), Hi-Tech(R), Tower(R), Haden(R), Mountain Breeze(R), Salton(R), and Pifco(R).
Certain matters discussed in this news release are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. These factors include: the Company's relationship and contractual arrangements with key customers, suppliers and licensors; the risks relating to pending legal proceedings All actions that are authorized or sanctioned by law and instituted in a court or a tribunal for the acquisition of rights or the enforcement of remedies. ; cancellation or reduction of orders; the timely development, introduction and customer acceptance of the Company's products; dependence on foreign suppliers and supply and manufacturing constraints; competitive products and pricing; economic conditions and the retail environment; the availability and success of future acquisitions; the Company's degree of leverage; international business activities; the risks related to intellectual property rights; the risks relating to regulatory matters and other risks and uncertainties detailed from time to time in the Company's Securities and Exchange Commission Filings.