Identity
- Trade Name
- TORLASE-Alexandrite and Nd: Yag laser FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- TORLASE FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00199284747210 FDA UDI
- 510(k) Number
- K222673 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General/multiple surgical frequency-doubled solid-state laser system
TORLASE-Alexandrite and Nd: Yag laser by Canadian Pioneer Medical Technology Corporation — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K222673 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Canadian Pioneer Medical Technology Corporation
Sources (1)
- FDA UDI f3a42893-393f-4690-9cac-fb4944eefccf 34 fields · synced Jun 8, 2026