FDA-Device2014-08-27Class II
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
Hyperion Medical
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.
Sold states
US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.
Affected count
3,346 brochures. Quantity not applicable to web site.
Manufactured in
15914 Midway Rd, Addison, TX, United States
Products
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2264-2014Don't want to check this manually?
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