Class III — Theralase Inc.
| Recalling firm | THERALASE INC. |
|---|---|
| Registered facility | Theralase Technologies Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Device was shipped without a Unique Device Identification (UDI) label. |
| Product | TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain. |
| Quantity | 41 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, WI and countries of AU, BH, CA, HK, JO, MX, PK, PH. |
| Initiated | 2019-09-26 |
| Classified | 2020-02-18 |
| Terminated | 2020-12-03 |
| Recall number | Z-0606-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Theralase Inc. (Z-0606-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84168/
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