TORLASE-Alexandrite and Nd: Yag laser

GUDID 00199284747210

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.

Canadian Pioneer Medical Technology Corporation

General/multiple surgical frequency-doubled solid-state laser system

• Primary Device ID: 00199284747210
• NIH Device Record Key: f3a42893-393f-4690-9cac-fb4944eefccf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TORLASE-Alexandrite and Nd: Yag laser
• Version Model Number: TORLASE
• Company DUNS: 204132773
• Company Name: Canadian Pioneer Medical Technology Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00199284747210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222673

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-16
• Device Publish Date: 2025-07-08

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• 00199284747210 - TORLASE-Alexandrite and Nd: Yag laser: 2025-07-16TORLASE 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.
• 00199284747210 - TORLASE-Alexandrite and Nd: Yag laser: 2025-07-16 TORLASE is a dual-wavelength long-pulse laser system combining Alexandrite (755 nm) and Nd:YAG (1064 nm) technologies for advanc
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