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

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

Clear

N/A - 08809447651453 Catalog Number :

Device Description : Clarity Hybrid Cooling Set(Hybrid Air Cooling Clip)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651460 Catalog Number :

Device Description : CLARITY ICD CAN ASSY 780g(ICD Canister)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651484 Catalog Number :

Device Description : Clairty 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 - 08809447651491 Catalog Number :

Device Description : Clarity Foot Switch Assy(Foot Switch)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DENTA II - 08809447651507 Catalog Number :

Device Description : DENTA II body(DENTA II laser system)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651521 Catalog Number :

Device Description : DENTA II Articulated Arm(DENTA II arm)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651545 Catalog Number :

Device Description : DENTA IITM 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 - 08809447651552 Catalog Number :

Device Description : DENTA II Zoom Handpiece[Optional]-Handpiece, Handpiece Head(DENTA Zoom Handpiece Set)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651569 Catalog Number :

Device Description : DENTA II Handpiece assembly (f=100mm)(DENTA Handpiece Set)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

N/A - 08809447651576 Catalog Number :

Device Description : DENTA II Micro Handpiece-Handpiece, Handpiece Head(DENTA Micro Handpiece Set)

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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