RegWardenFDA facility compliance records
Company

THERALASE INC.

6 recall(s) on record — most severe on record: Class III.

Recalls by year

FDA actions on record by year2019: 6 recalls20172018620192020202120222023202420252026
  • Recalls (6)

Registered facilities (1)

Recalls & enforcement

  • Class IIITerminated2019-09-26
    905 nm laser diodes may be below rated power output.
  • Class IIITerminated2019-09-26
    Device was shipped without a Unique Device Identification (UDI) label.
  • Class IIITerminated2019-09-26
    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
  • Class IIITerminated2019-09-26
    Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
  • Class IIITerminated2019-09-26
    660 nm laser diodes may be below rated power output.
  • Class IIITerminated2019-09-26
    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 rip…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “THERALASE INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9052867-theralase-inc/

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