FDA-Device2020-02-26Class III
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
Theralase Inc.
Hazard
Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)
Sold states
Worldwide distribution - US Nationwide and countries Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania.
Affected count
76 units
Manufactured in
41 Hollinger Rd, East York, Canada
Products
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1326-2020Don't want to check this manually?
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