Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Theralase with 7 device recalls and 2 510(k) clearances. The most recent is a device recall dated Sep 26, 2019: TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002Class III · Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) | Device recalls |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser SystemClass III · 905 nm laser diodes may be below rated power output. | Device recalls |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser SystemClass III · 660 nm laser diodes may be below rated power output. | Device recalls |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.Class III · Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets | Device recalls |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser SystemClass III · Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) stand | Device recalls |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.Class III · Device was shipped without a Unique Device Identification (UDI) label. | Device recalls |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.Class III · Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as | Device recalls |
| Nov 19, 2015 | TLC-2000 Therapeutic Medical Laser SystemK151816 · NHN | 510(k) clearances |
| Jul 11, 2005 | THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEMK050342 · NHN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
