FDA-Device2020-03-04Class III
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Theralase Inc.
Hazard
Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards
Sold states
U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Affected count
202 units
Manufactured in
41 Hollinger Rd, N/A, East York, N/A, Canada
Products
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1348-2020Don't want to check this manually?
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