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U.S. Department of Health and Human Services

Class 2 Device Recall DermaStyle Light therapy skin rejuvenator.

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  Class 2 Device Recall DermaStyle Light therapy skin rejuvenator. see related information
Date Initiated by Firm September 28, 2006
Date Posted November 07, 2006
Recall Status1 Terminated 3 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.
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 2		 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.
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