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) (6) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (4)

Premarket Exempt

Clear

LaseMD Ultra - 08809447653150 Catalog Number :

Device Description : AC POWER CABLE 3m

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LaseMD Ultra - 08809447653181 Catalog Number :

Device Description : Patient goggle

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LaseMD Ultra - 08809447653198 Catalog Number :

Device Description : cap_incubator

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LaseMD Ultra - 08809447653204 Catalog Number :

Device Description : LaseMD Ultra U120V case

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LUTRONIC GENIUS - 08809447653228 Catalog Number :

Device Description : M49D(7*7) TIP Lutronic GENIUS Macro size

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

LUTRONIC GENIUS - 08809447653242 Catalog Number :

Device Description : P14D(2*7) TIP Lutronic GENIUS

Device Class :

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

LUTRONIC GENIUS - 08809447653266 Catalog Number :

Device Description : P16D(4*4) TIP Lutronic GENIUS

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

LUTRONIC GENIUS - 08809447653280 Catalog Number :

Device Description : GENIUS M HANDPIECE

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

LaseMD Ultra - 08809447653990 Catalog Number :

Device Description : Optic_Goggle (Doctor)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

LaseMD Ultra - 08809447654010 Catalog Number :

Device Description : Wire Remote Interlock Key

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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