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

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HOLLYWOOD SPECTRA - 08809447654768 Catalog Number :

Device Description : DUAL FOCUSED DOTS HP_HOLLYWOOD SPECTRA

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HOLLYWOOD SPECTRA - 08809447654775 Catalog Number :

Device Description : Fractional Handpiece

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DermaV - 08809447655239 Catalog Number :

Device Description : CARTRIDGE_DermaV_2, 3, 5_7, 8_10_12, 12_14_16, 3X10 mm, FRACTIONAL

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DermaV - 08809447655246 Catalog Number :

Device Description : HANDPIECE ASSY_ST-A_GL19

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DermaV - 08809447655253 Catalog Number :

Device Description : COMPL_POLE_FIBER

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DermaV - 08809447655260 Catalog Number :

Device Description : WINDOW HOLDER ASSY_GL19

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DermaV - 08809447655277 Catalog Number :

Device Description : COMPL_BODY_ICD_S_DermaV_220V / USA / ICD

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DermaV - 08809447655284 Catalog Number :

Device Description : FOOT SWITCH_GL19

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DermaV - 08809447655291 Catalog Number :

Device Description : DermaV_MANUAL_REV00_USA

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

DermaV - 08809447655307 Catalog Number :

Device Description : ROLLER SET_GL19

Device Class : 2

Duns Number: 688282516

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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