Recall Z-0607-2020— Theralase Inc.
Class III · Terminated
Class III FDA medical device recall by Theralase Inc., initiated 2019-09-26, terminated 2020-12-03. It names one FDA 510(k) clearance: K151816. Product: TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.. Reason: 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..
- Recalling firm
- Theralase Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-09-26
- Terminated
- 2020-12-03
- Firm location
- East York, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.