FDA UDI
In Commercial Distribution
🇺🇸 United States
CANLASE-Alexandrite and Nd: Yag laser
DI: 00198715351606
·
Model: CANLASE
·
Canadian Pioneer Medical Technology Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CANLASE-Alexandrite and Nd: Yag laser
- Primary DI
- 00198715351606
- Version / Model
- CANLASE
- 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
- 2025-07-02
- Public Version
- 1
- Public Version Date
- 2025-07-10
- Public Version Status
- New
- Public Device Record Key
- 1328ce2f-1ba8-4468-b9ac-0978fb013df8
Device Description
CanLase™ is a true dual-wavelength Alexandrite (755 nm) and Nd:YAG (1064 nm) laser system designed for safe, effective treatments on all skin types. Ideal for permanent hair removal, vascular lesions, pigmentation, skin rejuvenation, and more. With high peak power, advanced cooling, and fast treatment speeds, CanLase is trusted by professionals seeking reliable, medical-grade results with cosmetic precision. FDA cleared and built for performance.
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 |
|---|---|---|---|---|
| 47877 | Dermatological 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 intended to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm); it may include additional glass/crystal rods and pumping options to achieve additional laser wavelengths. 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 | 00198715351606 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222673 | 000 |