Cell Robotics submits 510k to FDA on laser skin perforator.ALBUQUERQUE, N.M.--(BUSINESS WIRE)--Dec. 23, 1996--Cell Robotics International Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). :CRII CRII Cooperative Research in Information Infrastructure CRII Customer Returns Improvement Initiative ) announced that it has provided clinical data in a 510(k) pre-market notification to 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. regarding its new Lasette product. The Lasette is a laser finger perforator per·fo·rate v. per·fo·rat·ed, per·fo·rat·ing, per·fo·rates v.tr. 1. To pierce, punch, or bore a hole or holes in; penetrate. 2. that produces a small hole in a patient's finger to collect a few drops of blood in a nearly painless manner. The Lasette could be used by diabetic individuals to keep better track of their glucose levels by reducing discomfort and encouraging more frequent monitoring. The current 510(k) submittal covers use of the Lasette under professional supervision and would be used in hospitals, retirement homes, blood banks and specialty clinics. The Lasette reduces the possibility of cross contamination cross contamination Medical practice The passsage of pathogens indirectly from one Pt to another due to use of improper sterilization procedures, unclean instruments, or recycling of products from patients to health care workers caused by accidental sticks with the steel lancets currently used. It also eliminates the sharp-medical-waste problem associated with lancets. The laser opens a small hole in the fingertip fin·ger·tip n. The extreme end or tip of a finger. by vaporizing water molecules in the skin. There is no coagulation coagulation (kōăg'y  lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or of the blood, and it is easy to draw blood from the small hole. The current prototype of the Lasette is approximately 1-1/2" x 3-1/2" x 7" in size and fits into a small zipper zipperDevice for binding the edges of an opening, as on a garment or a bag. A zipper consists of two strips of material with metal or plastic teeth along the edges, and a sliding piece that interlocks the teeth when moved in one direction and separates them again when moved notebook similar to those used to carry daily planners. The Lasette is powered by AA batteries, either disposable or rechargeable. The company anticipates that after the Lasette has been used for several months in a professional setting under supervision of medical personnel, a 510(k) will be submitted for use by diabetics in a home environment. The home market of diabetic individuals numbers about 20 million worldwide. Most people with diabetes are supposed to test their glucose levels at least four times a day, although many do not test that frequently, primarily because of the pain experienced using steel lancets. Maintaining appropriate glucose levels is important for the long-term health and vitality of diabetic individuals. (The company cannot be certain of the FDA's response to a 510(k) submittal nor its decisions regarding extension of indications for use.) Cell Robotics International Inc. develops, manufactures and markets several proprietary medical and research laser devices and associated products with application niches in large markets. Additional information is available on the Cell Robotics homepage at http://www.cellrobotics.com/cell, by e-mail at crii@cellrobotics.com, or by telephone at 505/343-1131. CONTACT: Cell Robotics International Inc. 719/590-1793 Craig Rogers or Coffin Communications Group 818/789-0100 William F. Coffin Bryan G. Crane, ext. 102 Rachel Reynolds, ext. 113 |
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