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

Powered Laser Surgical Instrument (GEX) (4) Powered Laser Surgical Instrument With Microbeam\Fractional Output (ONG) (4) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (3) Skin Resurfacing Rf Applicator (OUH) (3) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (1)

Premarket Exempt

No Yes

Clear

SmoothCool HR - 08800020102737 Catalog Number :

Device Description : Unit (FDA)

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

SmoothCool - 08800020103017 Catalog Number :

Device Description : Phototherapy unit

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : ONF

Prescription Use : No

Device Count : 1

Edge - 08800020104014 Catalog Number :

Device Description : CO2 Fractional laser system

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : ONG

Prescription Use : No

Device Count : 1

Edge Arm - 08800020104021 Catalog Number :

Device Description : Articulated arm

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : ONG

Prescription Use : No

Device Count : 1

INTRAgen - 08800020105011 Catalog Number :

Device Description : Electrosurgical unit

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : OUH, GEI

Prescription Use : No

Device Count : 1

INTRAgen Tip - 08800020105028 Catalog Number :

Device Description : Sterile electrode

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : OUH, GEI

Prescription Use : No

Device Count : 1

INTRAgen Tip - 08800020105042 Catalog Number :

Device Description : Sterile electrode

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI, OUH

Prescription Use : No

Device Count : 1

SmoothCool HR - 08800020106018 Catalog Number :

Device Description : Phototherapy unit

Device Class :

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Edge ONE - 08800020110015 Catalog Number :

Device Description : CO2 Fractional laser system

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : ONG, GEX

Prescription Use : No

Device Count : 1

Edge ONE Arm - 08800020110022 Catalog Number :

Device Description : Articulated arm

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEX, ONG

Prescription Use : No

Device Count : 1

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