Recall Z-1348-2020— 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, Model Number TLC-2002. Reason: 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.
- Recalling firm
- Theralase Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-09-26
- Terminated
- 2020-12-03
- Firm location
- East York, N/A, 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, Model Number TLC-2002
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.