Lutronic Corporation

Address:56 Cheombok-ro, Dong-gu,Daegu Gyeongbuk,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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (6) Powered Laser Surgical Instrument (GEX) (4)

Premarket Exempt

Clear

N/A - 08809447650807 Catalog Number :

Device Description : Foot Switch (Foot switch assy : SPECTRA, GENIUS, ADVANTAGE, CLARITY, INFINI, eCO Foot Switch (Foot switch assy : SPECTRA, GENIUS, ADVANTAGE, CLARITY, INFINI, eCO2 Plus, DENTA II etc.)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447650821 Catalog Number :

Device Description : SPECTRA Manual for USA (Operator's manual)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

INFINI - 08809447650883 Catalog Number :

Device Description : INFINI MFR G U110V (INFINI Radiofrequency System)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 08809447650982 Catalog Number :

Device Description : INFINI MFR Handpiece (MFR Handpiece)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 08809447651019 Catalog Number :

Device Description : INFINI Handpiece cradle stand assy (Handpiece cradle)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 08809447651033 Catalog Number :

Device Description : INFINI MFR 49 TIP II 1 ea(MFR 49 Tip)

Device Class :

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 08809447651064 Catalog Number :

Device Description : INFINI TIP A-16 1 ea (MFR 16 Tip)

Device Class :

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 08809447651170 Catalog Number :

Device Description : INFINI Operator's Manual USA (Operator's Manual)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 08809447651187 Catalog Number :

Device Description : AC POWER CABLE 3M (eCO2, INFINI, Healite II, ADVANTAGE etc)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ADVANTAGE POWER PLUS - 08809447651279 Catalog Number :

Device Description : ADVNATAGE G 110V(ADVANTAGE laser console)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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