ILOODA.CO.,LTD

ILOODA.CO.,LTD

Address:9F, 25, Deokcheon-ro 152beon-gil,Anyang-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

Skin Resurfacing Rf Applicator (OUH) (7) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (6) Powered Laser Surgical Instrument (GEX) (5)

Premarket Exempt

No

Clear

Fraxis Duo Main Unit - 08800023200010 Catalog Number :

Device Description : FRX 2.0 Main Unit

Device Class : 2

Duns Number: 631129749

Premarket Exempt : No

Product Code : OUH, GEX, GEI

Prescription Use : Yes

Device Count : 1

Fraxis Duo ARM - 08800023200027 Catalog Number :

Device Description : FRX 2.0 Articualed Arm

Device Class : 2

Duns Number: 631129749

Premarket Exempt : No

Product Code : GEI, GEX, OUH

Prescription Use : Yes

Device Count : 1

Fraxis Duo Scanner H/P - 08800023200034 Catalog Number :

Device Description : FRX 2.0 Scanner H/P

Device Class : 2

Duns Number: 631129749

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Fraxis Duo Needle H/P - 08800023200041 Catalog Number :

Device Description : FRX 2.0 Needle H/P

Device Class : 2

Duns Number: 631129749

Premarket Exempt : No

Product Code : OUH, GEI

Prescription Use : Yes

Device Count : 1

Fraxis Duo 25Pin Needle Tip - 08800023200058 Catalog Number :

Device Description : MTR-AC-25

Device Class :

Duns Number: 631129749

Premarket Exempt : No

Product Code : GEI, OUH

Prescription Use : Yes

Device Count : 1

Secret RF Main Unit - 08800023200171 Catalog Number :

Device Description : MTR 2.0 Main Unit

Device Class : 2

Duns Number: 631129749

Premarket Exempt : No

Product Code : OUH

Prescription Use : Yes

Device Count : 1

Secret RF Small H/P - 08800023200188 Catalog Number :

Device Description : MTR 2.0 Small H/P

Device Class : 2

Duns Number: 631129749

Premarket Exempt : No

Product Code : GEI, OUH

Prescription Use : Yes

Device Count : 1

Secret RF Bigger H/P - 08800023200195 Catalog Number :

Device Description : MTR 2.0 Bigger H/P

Device Class : 2

Duns Number: 631129749

Premarket Exempt : No

Product Code : OUH, GEI

Prescription Use : Yes

Device Count : 1

VIKINI Main Unit - 08800023200218 Catalog Number : DET Main Unit

Device Class : 2

Duns Number: 631129749

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

VIKINI Laser H/P - 08800023200225 Catalog Number :

Device Description : DET Laser H/P

Device Class : 2

Duns Number: 631129749

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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