Lutronic Corporation

Address:DA-DONG 101/201/202, 245 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

Clear

N/A - 08809447651293 Catalog Number :

Device Description : Advantage CART ASSY(Cart)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651316 Catalog Number :

Device Description : ADVANTAGE Assy Foot switch (optional)(Footswitch)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651323 Catalog Number :

Device Description : ADVANTAGE ASSY HANDPIECE 10x10mm SAHR800(ADVANTAGE D1-800 handpiece)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651347 Catalog Number :

Device Description : ADVANTAGE ASSY HANDPIECE 10x30mm BAHR800(ADVANTAGE D3-800 handpiece)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651361 Catalog Number :

Device Description : Advantage Operator’s Manual (Operator's Manual)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651378 Catalog Number :

Device Description : ADVANTAGE Cooling gel(Coupling Gel)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651385 Catalog Number :

Device Description : ADVANTAGE ASSY HANDPIECE 10x10mm BAHR1060(ADVANTAGE D1-1064 handpiece)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

CLARITY - 08809447651408 Catalog Number :

Device Description : CLARITY-LPC, ICD 1.5 body(CLARITY LPC Laser System)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651422 Catalog Number :

Device Description : CLARITY HANDPIECE+FIBER ASSY (Optical fiber with handpiece)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651446 Catalog Number :

Device Description : Clarity ICD CARTRIDGE SET

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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