510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Theralase Technologies Inc.

Toronto Ontario, CA

Theralase Technologies Inc. appears in FDA device records in Toronto Ontario, CA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
7
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Theralase Technologies Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Theralase, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Theralase Technologies Inc. between 2005 and 2015. The busiest year on record is 2005, with 1. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Theralase Technologies Inc., by decision year
YearClearances
20051
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K151816TLC-2000 Therapeutic Medical Laser SystemNHNSubstantially Equivalent
K050342THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEMNHNSubstantially Equivalent

Registered establishments

FDA registered establishments for Theralase Technologies Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30036144903003614490Theralase Technologies Inc.41 Hollinger Road, Toronto Ontario M4B 3G4 CA2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1266-2020TLC-2000 Therapeutic Medical Laser SystemLaser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standardClass IIITerminated
Z-1326-2020TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.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)Class IIITerminated
Z-1353-2020TLC-2000 Therapeutic Medical Laser System660 nm laser diodes may be below rated power output.Class IIITerminated
Z-1354-2020TLC-2000 Therapeutic Medical Laser System905 nm laser diodes may be below rated power output.Class IIITerminated
Z-1348-2020TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002Power 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) standardsClass IIITerminated
Z-0607-2020TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.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.Class IIITerminated
Z-0606-2020TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.Device was shipped without a Unique Device Identification (UDI) label.Class IIITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain