TORLASE-Alexandrite and Nd: Yag laser

Primary DI
00199284747210
Brand
TORLASE-Alexandrite and Nd: Yag laser
Company
Canadian Pioneer Medical Technology Corporation
Model
TORLASE
Device description
TORLASE is a dual-wavelength long-pulse laser system combining Alexandrite (755 nm) and Nd:YAG (1064 nm) technologies for advanced aesthetic applications. It is designed for permanent hair reduction on all skin types, including tanned and dark skin. TORLASE effectively treats benign pigmented lesions, facial and leg veins, vascular lesions, angiomas, hemangiomas, venous lakes, and port wine stains. It also provides skin rejuvenation, diffuse redness reduction, wrinkle reduction, and PFB (pseudofolliculitis barbae) treatment. The system features adjustable spot sizes, high-tech skin cooling, and customizable treatment parameters to optimize safety and clinical outcomes. TORLASE is suitable for dermatology clinics, aesthetic centers, and medical spas, and complies with applicable medical device standards.
Published
2025-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222673000Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)2022-11-17GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199284747210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199284747210001992847472101992847472100199284747210

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical frequency-doubled solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
204132773
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199284314580CPMT Ares – Quadruple Laser SystemCPMT Ares 2025-07-08
00198715351606CANLASE-Alexandrite and Nd: Yag laser CANLASE2025-07-02
00198715225501PureLase PureLase 2025-06-30
00199284910331EMSMagnaCore 2025-06-30
00198715809718CPMT AquaProCPMT AquaPro2024-12-31

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