Jeisys Medical Inc.

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) (9) Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (OHV) (1)

Premarket Exempt

No Yes

Clear

LIPOcel - 08800020100009 Catalog Number :

Device Description : Focused Ultrasound for tissue heat or mechanical cellular disruption

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : OHV

Prescription Use : Yes

Device Count : 1

INTRAcel RF Microneedle System - 08800020100177 Catalog Number :

Device Description : Fractional RF Micro Needle System

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

INTRAcel RF Microneedle System - 08800020100184 Catalog Number :

Device Description : Fractional RF Micro Needle System

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020100191 Catalog Number :

Device Description : POTENZA Tip (Sterile micro needle electrode CP-21 Tip)

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020100207 Catalog Number :

Device Description : POTENZA Tip (Sterile micro needle electrode Combo-box)

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Demokit - 08800020100214 Catalog Number :

Device Class : 2

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020100221 Catalog Number :

Device Description : CP-21 Tip (FDA/1EA)

Device Class :

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020100238 Catalog Number :

Device Description : I-49 Tip (FDA/1EA)

Device Class :

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020100245 Catalog Number :

Device Description : S-49 Tip (FDA/1EA)

Device Class :

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

POTENZA Tip - 08800020100252 Catalog Number :

Device Description : I-25 Tip (FDA/1EA)

Device Class :

Duns Number: 690275362

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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