May 27, 1997
We regret to inform you that your certification is incomplete, and therefore inadequate, as submitted. Your certification states that “the computer hardware, firmware and software in my laser allow it to perform all the procedures of the PMA approved device in an identical manner. ” A certification must establish that the limitations of operation required...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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15148 Springview St
Tampa, FL 33624
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