FDA.reportPublic FDA data

CANLASE-Alexandrite and Nd: Yag laser

Primary DI
00198715351606
Brand
CANLASE-Alexandrite and Nd: Yag laser
Company
Canadian Pioneer Medical Technology Corporation
Model
CANLASE
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.
Published
2025-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
GFEBrush, Dermabrasion, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222673000Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)2022-11-17GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198715351606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198715351606001987153516061987153516060198715351606

GMDN Terms#

Term, Definition table
TermDefinition
Dermabrasion brush, rotaryA device with wire bristles that is rotated in a power-driven tool to plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) to remove scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
204132773
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199284314580CPMT Ares – Quadruple Laser SystemCPMT Ares 2025-07-08
00199284747210TORLASE-Alexandrite and Nd: Yag laser TORLASE 2025-07-08
00198715225501PureLase PureLase 2025-06-30
00199284910331EMSMagnaCore 2025-06-30
00198715809718CPMT AquaProCPMT AquaPro2024-12-31

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Primary DI, Brand, Company table
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G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
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08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
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08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
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08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
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