FDA Medical Device Recalls (openFDA)
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 number
- Z-1308-2009
- Recalling firm
- Sybaritic, Inc
- 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.
- Status
- Terminated
- Initiated
- 2008-06-18
- Posted
- 2009-04-30
- Terminated
- 2012-07-05
- 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
- Lot, serial or model codes
- Serial Number 170401
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHS
- Firm FEI
- 2131125
- Firm city
- Bloomington
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28