FDASeptember 26, 2019device
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.
What to do
FDA enforcement status: Terminated
Brands named
theralase
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATLC-2000 Therapeutic Medical Laser System2019-09-26
- FDATLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.2019-09-26
- FDATLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-20022019-09-26
- FDATLC-2000 Therapeutic Medical Laser System2019-09-26
- FDATLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.2019-09-26
- FDATLC-2000 Therapeutic Medical Laser System2019-09-26
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