Tanda Beauty Canada, Inc

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Light Based Over The Counter Wrinkle Reduction (OHS) (4) Over-The-Counter Powered Light Based Laser For Acne (OLP) (3) Powered Laser Surgical Instrument (GEX) (3)

Premarket Exempt

Clear

Tanda - 00806248004929 Catalog Number : HU-FG00621

Device Description : Home use, hand held, blue light (414nm ) LED emitting device that is used for th

Device Class :

Duns Number: 248047115

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Tanda - 00806248004936 Catalog Number : HU-FG00631

Device Description : Home use, hand held, blue light (414nm ) LED emitting device that is used for th

Device Class : 2

Duns Number: 248047115

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Tanda - 00806248005186 Catalog Number : HU-FG00961

Device Description : Home use, hand held, blue light (414nm ) LED emitting device that is used for th

Device Class : 2

Duns Number: 248047115

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Iluminage - 00806248005322 Catalog Number : HU-FG00851US

Device Description : Battery powered, home use (OTC) diode laser indicated for use in the treatment o

Device Class : 2

Duns Number: 248047115

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Me - 00806248006114 Catalog Number : HU-FG01271

Device Description : Home use, hand held, rechargeable blue light (414nm ) LED emitting device that i

Device Class : 2

Duns Number: 248047115

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

Iluminage - 00806248006336 Catalog Number : HU-CO00621

Device Description : Battery powered, home use (OTC) diode laser indicated for use in the treatment o

Device Class : 2

Duns Number: 248047115

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Me - 00806248006459 Catalog Number : HU-FG01281

Device Description : Home use, hand held, rechargeable red light (660nm ) LED emitting device that is

Device Class :

Duns Number: 248047115

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

Me - 00806248007241 Catalog Number : HU-FG01721

Device Description : Home use, hand held, rechargeable blue light (414nm ) LED emitting device that i

Device Class : 2

Duns Number: 248047115

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

Me - 00806248007289 Catalog Number : HU-CO00821

Device Description : Home use, hand held, rechargeable blue light (414nm ) LED emitting device that i

Device Class : 2

Duns Number: 248047115

Premarket Exempt : No

Product Code : OLP

Prescription Use : No

Device Count : 1

Iluminage - 00806248007296 Catalog Number :

Device Description : Battery powered, home use (OTC) diode laser indicated for use in the treatment o

Device Class : 2

Duns Number: 248047115

Premarket Exempt : No

Product Code : OHS

Prescription Use : No

Device Count : 1

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