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U.S. Department of Health and Human Services

Class 2 Device Recall Lumi 8 Intense LED Light Facial System

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  Class 2 Device Recall Lumi 8 Intense LED Light Facial System see related information
Date Initiated by Firm June 18, 2008
Date Posted April 30, 2009
Recall Status1 Terminated 3 on July 05, 2012
Recall Number Z-1308-2009
Recall Event ID 51708
Product Classification Light Based Over The Counter Wrinkle Reduction - Product Code OHS
Product Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9220 James Ave South Minneapolis, Minnesota 55431., Mode of Operation: Operation with Intermittent/continuous load, Visible and Invisible LED Radiation, Class 3R LED Product, Refer to IEC 60825-2001 for further information., Input: 100 -230 V AC 50/60 HZ Power Input: 1509 V A....Protective Eyewear required Wavelength 590 & 630 nm.
Code Information Serial Number 170401
Recalling Firm/
Manufacturer		 Sybaritic, Inc
9220 James Ave S
Bloomington MN 55431-2302
For Additional Information Contact
952-888-8282
Manufacturer Reason
for Recall		 Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.
FDA Determined
Cause 2		 PMA
Action Letter sent to consignee on June 18, 2008 confirming a phone conversation on June 18 regarding the required Field Correction of the device. The letter also described the changes to be performed by the local technician to be in compliance with the FDA. The customer was asked to allow the technician access to their LUMI 8 system; allow technician to replace the computer chips and owner's manual; give current LUMI 8 owner's manual to technician; and sign the work order provided by the technician. Questions should be directed to Fred Berg at 800-445-8418 or fberg@sybaritic.com.
Quantity in Commerce 1
Distribution USA: MI
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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