August 27, 2014Medical DevicesFDA
Hyperion Medical recalls All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and
Hazard: Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could be used with a 15 mm hand piece.