Lutronic Corporation

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) (10)

Premarket Exempt

No

Clear

N/A - 08809447650012 Catalog Number :

Device Description : CLARITY ICD CAN ASSY 360g (ICD Canister)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SPECTRA - 08809447650265 Catalog Number :

Device Description : Spectra-Option body U120V (SPECTRA laser system)

Device Class :

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SPECTRA - 08809447650272 Catalog Number :

Device Description : SPECTRA SL body U120V (SPECTRA laser system)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447650333 Catalog Number :

Device Description : Spectra-standard ARM (Articulated arm)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447650500 Catalog Number :

Device Description : Spectra 1-7mm ZOOM HP (20%UP) (Zoom handpiece)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447650517 Catalog Number :

Device Description : Spectra 3-8 ZOOM COLLIMATED HP (20%UP) (8mm-Zoom-collimated handpiece)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447650548 Catalog Number :

Device Description : Spectra 5mm Dye Hand piece (585m) (5mm-SD585)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447650562 Catalog Number :

Device Description : Spectra SD585 HP (2mm-SD585)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447650579 Catalog Number :

Device Description : Spectra SD650 HP (2mm-SD650)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447650777 Catalog Number :

Device Description : Spectra Lotion 1 bottle/ for SPECTRA & PICOPLUS

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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