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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Sybaritic, Inc
Lot Codes / Batch Numbers
Serial Number 170401
Products Sold
Serial Number 170401
Sybaritic, Inc is recalling Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9220 James Ave South Minneapolis, Minnesota due to Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MI
Page updated: Jan 10, 2026