510(k) K151816 ยท NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
TLC-2000 Therapeutic Medical Laser System
| Applicant | Theralase, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Nov 19, 2015 |
| Received | Jul 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151816
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2020 | Theralase Inc. TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 Terminated |
NHN | None listed |
| Feb 13, 2020 | Theralase Inc. TLC-2000 Therapeutic Medical Laser System Terminated |
NHN | None listed |
| Feb 13, 2020 | Theralase Inc. TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain. Terminated |
NHN | None listed |
| Feb 13, 2020 | Theralase Inc. TLC-2000 Therapeutic Medical Laser System Terminated |
NHN | None listed |
| Dec 5, 2019 | Theralase Inc. TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain. Terminated |
NHN | None listed |
| Dec 5, 2019 | Theralase Inc. TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain. Terminated |
NHN | None listed |
| Sep 26, 2019 | Theralase Inc. TLC-2000 Therapeutic Medical Laser System Terminated |
NHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.