FDA-Device2019-12-11Class III
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
Theralase Inc.
Hazard
Device was shipped without a Unique Device Identification (UDI) label.
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
41 units
Manufactured in
41 Hollinger Rd, East York, Canada
Products
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0606-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief