Identity
- Trade Name
- CANLASE-Alexandrite and Nd: Yag laser FDA UDI
- Generic Name
- Dermatological frequency-doubled solid-state laser system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- CANLASE FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00198715351606 FDA UDI
- 510(k) Number
- K222673 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological 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: Dermatological frequency-doubled solid-state laser system
CANLASE-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 1328ce2f-1ba8-4468-b9ac-0978fb013df8 34 fields · synced Jun 8, 2026