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Sign in to claim this brandTheralase, Inc.
US
Last updated May 31, 2026
Information
- Country
- US
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- Website
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 258595334
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Theralase | TLC-1000 | FDA UDI | Class II | Active |
| Theralase | TLC-2000 | FDA UDI | Class II | Active |
| TLC-2000 Therapeutic Medical Laser System | K151816 | FDA 510(k) | Class II | Active |
| Theralase Tlc-1000 Therapeutic Medical Laser System | K050342 | FDA 510(k) | Class II | Active |
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FDA Recalls (7)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 26, 2019 | Z-1266-2020 | — | terminated | Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard |
| Sep 26, 2019 | Z-0607-2020 | — | terminated | Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark. |
| Sep 26, 2019 | Z-1348-2020 | — | terminated | 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 |
| Sep 26, 2019 | Z-1354-2020 | — | terminated | 905 nm laser diodes may be below rated power output. |
| Sep 26, 2019 | Z-1353-2020 | — | terminated | 660 nm laser diodes may be below rated power output. |
| Sep 26, 2019 | Z-0606-2020 | — | terminated | Device was shipped without a Unique Device Identification (UDI) label. |
| Sep 26, 2019 | Z-1326-2020 | — | terminated | 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) |