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.
Publicado el 27 de agosto de 2014 · Inicio del retiro: 20 de noviembre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Hyperion Medical
- Distribuidor
- US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.
- Lote
- All brochures and online literature printed before November 20, 2013.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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