TORLASE-Alexandrite and Nd: Yag laser
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Basic Information
- Brand Name
- TORLASE-Alexandrite and Nd: Yag laser
- Primary DI
- 00199284747210
- Version / Model
- TORLASE
- Company Name
- Canadian Pioneer Medical Technology Corporation
- Labeler DUNS
- 204132773
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-08
- Public Version
- 1
- Public Version Date
- 2025-07-16
- Public Version Status
- New
- Public Device Record Key
- f3a42893-393f-4690-9cac-fb4944eefccf
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36150 | General/multiple surgical frequency-doubled solid-state laser system | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00199284747210 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222673 | 000 |