FDA Device recall Z-1354-2020
TLC-2000 Therapeutic Medical Laser System
- FDA Device
- Class III
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class III recall of TLC-2000 Therapeutic Medical Laser System by Theralase, citing 905 nm laser diodes may be below rated power output.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1354-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-09-26 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Theralase |
| Distribution | n/a |
Product
TLC-2000 Therapeutic Medical Laser System
Reason
905 nm laser diodes may be below rated power output.
Identifiers
| code_info | Serial Numbers: 3245 to 3336 inclusive |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1354-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.