Class 2 Device Recall DermaStyle Light therapy skin rejuvenator.

• Date Initiated by Firm: September 28, 2006
• Date Posted: November 07, 2006
• Recall Status: Terminated on March 13, 2012
• Recall Number: Z-0156-2007
• Recall Event ID: 36406
• Product Classification: Light therapy - Product Code MOQ
• Product: DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes; portable home therapy; Lumiport LLC.
• Code Information: All units sold before 08/01/2006.
• FEI Number: 3005952043
• Recalling Firm/ Manufacturer: Lumiport, LLC; 5255 North Edgewood Drive, Suite 235; Provo UT 84604
• For Additional Information Contact: 801-804-7084
• Manufacturer Reason for Recall: Incorrect charger; batteries may overheat , catch fire or explode while being charged with the charger enclosed with the device.
• FDA Determined Cause: Other
• Action: Individual customers were contacted through e-mail and/or telephone beginning 09/28/2006. They were told to stop charging and using their current DermaStyle and to destroy it to prevent accidental usage. New replacements will be mailed to all customers.
• Quantity in Commerce: 2480 units
• Distribution: World wide Distribution-sales by direct mail or internet-USA and Canada
• 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.