Lutronic Corporation

Address:Poskom Tower, 3F-4F, 227, Sowon-ro,Goyang-si Gyeonggi,KR

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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

Powered Laser Surgical Instrument (GEX) (7) Lamp, Infrared, Therapeutic Heating (ILY) (3)

Premarket Exempt

Clear

eCO2 - 08809447651583 Catalog Number :

Device Description : eCO2 PLUS(USA) body(eCO2 Plus laser system)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651606 Catalog Number :

Device Description : eCO2 PLUS(USA) ARM (Articulated Arm)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651620 Catalog Number :

Device Description : eCO2 SPⅢ Handpiece Set(F100 Handpiece)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651637 Catalog Number :

Device Description : eCO2 SPⅢ Micro Handpiece Set(F50 Handpiece)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651644 Catalog Number :

Device Description : eCO2 SPⅢ ZOOM Handpiece Set(Zoom Handpiece)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651651 Catalog Number :

Device Description : eCO2 Manual(Operator's Manual)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651668 Catalog Number :

Device Description : eCO2 Foot Switch(Foot Switch)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651675 Catalog Number :

Device Description : Healite II 830&590nm Head (830/590nm head)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Healite II - 08809447651699 Catalog Number :

Device Description : Healite Body Assy(System Main Body)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

N/A - 08809447651712 Catalog Number :

Device Description : Healite II Manual(Operator's Manual)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

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