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The Laser Institute |
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Phone: 954- 565-1999 Fax: 954-564-4326 E-mail: info@nowlaser.com |
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General Information |
ComplianceQ. Is Low-Level Laser Therapy FDA approved? A. The FDA clears for market devices and specific indications for use, this is sometime referred to by persons outside the FDA as “FDA Approval”, although it is a term unacceptable to the FDA. All Erchonia devices have received a FDA market clearance or were self certified in accordance to FDA regulation. Q. Are Erchonia Low-Level Laser devices tested to ensure safety? A. Erchonia Corporation develops, desigs, and manufactures devices in accordance to both FDA and International standards for Medical Device Quality Standards. Prior to release to production, finished devices are tested to Medical Safety Standards for Laser Controls, EMC, and Safety. ContraindicationsQ. Are there any conditions which would prevent me from low-level laser treatment? A. There are no code regulated contraindications; however, since there are no long term evaluations on certain conditions, Erchonia does not recommend use on pregnant women or persons with a pace maker. Q. Does Low-Level Laser therapy cause heat damage or cancer in the tissue? A. No, low-level laser by virtue of design is non-heat producing and does not alter the cell structure. The laser irradiation is non-ionizing, meaning it does not collect in the tissue. Q. Are there any side effects? A. Some persons have reported a sense of deep relaxation that may cause drowsiness Q. Are there any complications to the treatments? A. There are no known and / or published adverse effects of Low-Level Laser Therapy. |
