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U.S. Department of Health and Human Services

Class 2 Device Recall HyperBlue 1530, multiuse diode laser

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  Class 2 Device Recall HyperBlue 1530, multiuse diode laser see related information
Date Initiated by Firm November 20, 2013
Date Posted August 18, 2014
Recall Status1 Terminated 3 on May 15, 2015
Recall Number Z-2264-2014
Recall Event ID 67814
Product Classification Lasers for temporary increase of clear nail in patients with onychomycosis - Product Code PDZ
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.
Code Information All brochures and online literature printed before November 20, 2013.
Recalling Firm/
Manufacturer		 Hyperion Medical
15914 Midway Rd
Addison TX 75001-4261
Manufacturer 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.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Hyperion Medical notified all sales representatives by private courier letter to stop distributing the the sales brochure and return or destroy existing stocks of the brochure. Sales representatives were instructed not to demonstrate the 15 mm hand piece with the HyberBlue 1530 and to remove from any of their individual internet web sites any information about multiple wavelength use or the 15 mm handpiece accessory. The letter to the sales representatives included delivery confirmation. The information on the firm's web site for this product regarding multiple wavelengths and the 15 mm handpiece was removed. For further information please call (214) 914-3133.
Quantity in Commerce 3,346 brochures. Quantity not applicable to web site.
Distribution US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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