Device product
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.
Z-2264-2014
Product summary
- Firm
- Hyperion Medical
- Event
- Event 67814
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,346 brochures. Quantity not applicable to web site.
- Official record key
device-enforcement:Z-2264-2014
Official wording
Reason: 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.
Code information: All brochures and online literature printed before November 20, 2013.
Distribution pattern: US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.
Derived failure modes
-
Unknown
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.