Recall Z-2264-2014— Hyperion Medical
Class II · Terminated
Class II FDA medical device recall by Hyperion Medical, initiated 2013-11-20, terminated 2015-05-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Hyperion Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-20
- Terminated
- 2015-05-15
- Firm location
- Addison, TX, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.