Jeisys Medical Inc.

Address:307, 308, 401, 410, Daeryung Techno Town 8th, 96 Gamasan-ro, Geumcheon-gu,Seoul,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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (8) Powered Laser Surgical Instrument (GEX) (2) Skin Resurfacing Rf Applicator (OUH) (1)

Premarket Exempt

No Yes

Clear

POTENZA Tip - 08800020101143 Catalog Number :

Device Description : A1-15 (FDA/1EA)

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020101150 Catalog Number :

Device Description : C21-1 Tip (FDA/1EA)

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020101167 Catalog Number :

Device Description : C21-2 Tip (FDA/1EA)

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020101174 Catalog Number :

Device Description : C9 Tip (FDA/1EA)

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020101181 Catalog Number :

Device Description : I-16 Tip (FDA/1EA)

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020101198 Catalog Number :

Device Description : S-16 Tip (FDA/1EA)

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020101204 Catalog Number :

Device Description : P1-08 (FDA/1EA)

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

INTRAgen Tip - 08800020101211 Catalog Number :

Device Description : INTRAgen Tip (KT-15)

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : OUH, GEI

Prescription Use : No

Device Count : 1

Tri-Beam Nd:YAG Laser System - 08800020102010 Catalog Number :

Device Description : POWERED LASER SURGICAL INSTRUMENT

Device Class :

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

TRI-BEAM Arm - 08800020102027 Catalog Number :

Device Description : Articulated Arm

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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