Facility

Theralase Technologies Inc.

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

Key facts

6recalls · worst Class III

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003614490
Establishment type	Manufacture Medical Device
Location	41 Hollinger Road Toronto Ontario, CA M4B 3G4
Registration status	Active · expires 2026
Parent company	THERALASE INC. (owner-operator 9052867)
Brand names	Theralase

Activity by year

Recalls (6)

Devices registered here (1)

Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Product code NHN (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.5500

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…

All facilities operated by THERALASE INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Theralase Technologies Inc. (FEI 3003614490) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003614490-theralase-technologies-inc/

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