CDRH promo untitled letters.The following untitled letters were issued by FDA's Division of Promotion and Advertising, Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. , Office of Compliance. Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval. 12541W Esthetica Laser Hair Removal Epilation performed by laser was performed experimentally for about 20 years before it became commercially available in the mid 1990s. Intense Pulsed Light (IPL) epilators, though technically not a laser, use xenon flash lamps that emit full spectrum light. Center, Allentown, PA, Jan 17, 2002. (CDRH-OC) The agency objected to a statement on the website: "The Cynosure cy·no·sure n. 1. An object that serves as a focal point of attention and admiration. 2. Something that serves to guide. Apogee Alexandrite alexandrite type of chrysoberyl typifying undying devotion. [Gem Symbolism: Jobes, 67] See : Loyalty Laser has the highest rating from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for permanent hair reduction." The agency noted that it does not rate lasers. Furthermore, all lasers for hair removal are substantially equivalent and are classified as Class II devices. O-L Use, Web, F-B F-B Forward - Backward (radar image analysis) 12542W J.D. Marvel, Champlain, NY, Jan. 28, 2002 (CDRH-OC). The untitled letter was a follow-up to previous correspondence from June 2001 in which FDA noted that the company's device, the Super Mini Ear, was being falsely promoted in that it claimed to be superior to other hearing aids and "light and compact so you won't even feel it." The hearing aid, however, is quite large, the letter noted. The agency felt that J.D. Marvel had inadequately ad-dressed the aforementioned issues and that the font type requiring either a medical evaluation or a signed waiver prior to purchase was too small. MDR MDR, n See multidrug resistance. MDR, n the abbreviation for minimum daily requirement, specifically the Minimum Daily Requirements for Specific Nutrients compiled by the United States Food and Drug Administration. 12543W International Brachytherapy, Norcross, GA, Jan. 2, 2002. (CDRH-OC) FDA objected to the company's promotional piece for product InterStrand Radionuclides, specifically to statements claiming it "eliminates seed migration" and "will not jam." This is misleading as the labeling cleared for the product states that the radioactive seeds are held in place by the monofilament suture and that the suture minimizes seed movement or migration. The agency further emphasized that no data was ever submitted by the firm to indicate that InterStrand eliminates seed migration. O-L Use, Lab 12544W System Optics Laser Vision Center, Tallmadge, OH, Dec. 20, 2001 (CDRH-OC). A review of the laser center's website revealed that it was promoting unapproved uses for products NIDEK EC-5000 Excimer Laser and Array Multifocal IOL. FDA noted that NIDEK EC-5000 Excimer Laser is approved only for myopia with or without astigmatism astigmatism (əstĭg`mətĭz'əm), type of faulty vision caused by a nonuniform curvature in the refractive surfaces—usually the cornea, less frequently the lens—of the eye. , but that the website also promotes it for hyperopia. Further, the Array Multifocal IOL is approved for "the visual correction of aphakia in persons 60 years of age or older in whom cataractous lenses have been removed," but the website also promotes the product for presbyopia Presbyopia Definition The term presbyopia means "old eye" and is a vision condition involving the loss of the eye's ability to focus on close objects. in patients younger than 60 years of age. O-L Use, Web 12545W World Optics, Agoura, CA, Jan. 17, 2002 (CDRH-OC) FDA reviewed the company's website and determined that product ChromaGen Contact Lenses was being falsely promoted. Unsubstantiated claims included that the lenses "enhance color vision deficiencies" and that the lenses may be used for the treatment of dyslexia and the reduction of migraines. O-L Use, Web |
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