Recall Z-1308-2009 ยท OHS Light Based Over The Counter Wrinkle Reduction
Sybaritic, Inc
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.
| Date | Apr 30, 2009 (initiated Jun 18, 2008) |
| Status | Terminated |
| Reason | Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported. |
| Root cause | 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 | 1 |
| Distribution | USA: MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.