FDA-Device2019-12-11Class III
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Theralase Inc.
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.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, WI and countries of AU, BH, CA, HK, JO, MX, PK, PH.
Affected count
306 units
Manufactured in
41 Hollinger Rd, East York, Canada
Products
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0607-2020Don't want to check this manually?
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