Data / Medical devices / Canada / Theralase Technologies Inc.
Theralase Technologies Inc.: FDA-registered device maker in Toronto Ontario, Canada, 2 510(k) clearances
Theralase Technologies Inc. is registered with the FDA (registration 3003614490) in Toronto Ontario, Canada. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 19, 2015. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003614490
- Address
- 41 Hollinger Road, Toronto Ontario, Canada, M4B 3G4
- Owner or operator
- THERALASE INC. (9052867)
- Roles
- Manufacturer
- First device listed
- March 7, 2003
- Registered through
- 2027
- Brand names listed
- TLC-2000 Therapeutic Medical Laser System, Theralase
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | NHN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2015 | K151816 | TLC-2000 Therapeutic Medical Laser System | NHN | Substantially Equivalent | Theralase, Inc. | accessdata.fda.gov |
| July 11, 2005 | K050342 | THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM | NHN | Substantially Equivalent | Theralase, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 26, 2019 | 84846 | Class III | Terminated | TLC-2000 Therapeutic Medical Laser System | Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard | accessdata.fda.gov |
| September 26, 2019 | 84845 | Class III | Terminated | TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain. | 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 ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification) | accessdata.fda.gov |
| September 26, 2019 | 84844 | Class III | Terminated | TLC-2000 Therapeutic Medical Laser System | 660 nm laser diodes may be below rated power output. | accessdata.fda.gov |
| September 26, 2019 | 84843 | Class III | Terminated | TLC-2000 Therapeutic Medical Laser System | 905 nm laser diodes may be below rated power output. | accessdata.fda.gov |
| September 26, 2019 | 84842 | Class III | Terminated | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 | 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 | accessdata.fda.gov |
| September 26, 2019 | 84168 | Class III | Terminated | TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain. | Device was shipped without a Unique Device Identification (UDI) label. | accessdata.fda.gov |
Compare with other makers
Updated February 13, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.