Question 1

What types of devices does Jeisys Medical Inc. manufacture?

Accepted Answer

Jeisys Medical Inc. manufactures electrosurgical systems, radio-frequency skin and body contouring systems, radio-frequency ablation systems, line-powered surgical power tool system motors, radio-frequency skin contouring system applicator tips, intense pulsed light skin surface treatment systems, dermatological carbon dioxide laser systems, and foot-switches for electrical use.

These devices are classified as Class I, Class II, and Class IIb and are listed in the Eudamed, FDA 510(k), and FDA UDI databases. The company is based in South Korea (KR).

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Jeisys Medical Inc. based?

Accepted Answer

Jeisys Medical Inc. is based in South Korea, as indicated by the country code KR in the device data. This location is explicitly stated in the SUMMARY section and is the only geographic information provided about the company’s headquarters or operational base.

Question 3

In which regulatory registries are Jeisys Medical Inc.'s devices listed?

Accepted Answer

Jeisys Medical Inc.'s devices are listed in the Eudamed, FDA 510(k), and FDA UDI databases. This information is directly stated in the LISTED IN field and repeated in the SUMMARY, confirming the registries where the company’s devices appear without implying any approval or clearance status for the company itself.

Question 4

How are Jeisys Medical Inc.'s devices classified under regulatory systems?

Accepted Answer

Jeisys Medical Inc.'s devices are classified as Class I, Class II, and Class IIb. This classification is explicitly provided in the DEVICE CLASSES field and reiterated in the SUMMARY, indicating that the company’s products span multiple risk-based categories depending on the specific device type and intended use.

Device	Model / Reference	Registries	Class	Status
POTENZA Tip	Combo-box	FDA UDI	Class II	Active
Jeisys Medical Inc.	DENSITY Noir	FDA UDI	Class II	Active
Density Handpiece	Density Handpiece	FDA UDI	Class II	Active
INTRAcel RF Microneedle System	INTRAcel PRO	FDA UDI	Class II	Active
Edge Arm	Edge Arm	FDA UDI	Class II	Active
POTENZA Tip	A1-15	FDA UDI	Class II	Active
Density B-Tip II	Density B-Tip II	FDA UDI	Class II	Active
Density I-Tip	Density I-Tip	FDA UDI	Class II	Active
Jeisys Medical Inc.	ALPHA Tip	FDA UDI	Class II	Active
DENZA Handpiece	DENZA Handpiece	FDA UDI	Class II	Active
DENZA B-Tip II	DENZA B-Tip II	FDA UDI	Class II	Active
Edge	Edge	FDA UDI	Class II	Active
POTENZA Tip	A1-15	FDA UDI	Class II	Active
POTENZA Demokit	Demokit	FDA UDI	Class II	Active
POTENZA Tip	S-16	EUDAMEDFDA UDI	Class II	Active
POTENZA Tip	S-49 Tip	FDA UDI	Class II	Active
POTENZA Tip	A1-12	FDA UDI	Class II	Active
S-49 Electrode	S-49	EUDAMEDFDA UDI	Class IIb	Active
Smoothcool Hr System	K082911	FDA 510(k)	Class II	Active
P-Nain System	K072833	FDA 510(k)	Class II	Active
Smoothcool	K092326	FDA 510(k)	Class II	Active
Hilthera 4.0	K141861	FDA 510(k)	Class II	Active
SmoothCool HR System	K213484	FDA 510(k)	Class II	Active
INTRAcel RF Microneedle System	K183284	FDA 510(k)	Class II	Active
SmoothCool HR System	K223685	FDA 510(k)	Class II	Active
EdgeOne CO2 Laser	K162169	FDA 510(k)	Class II	Active
INTRAGen	K142833	FDA 510(k)	Class II	Active
INTRAcel Premium Fractional RF Micro Needle (FRM) System	K153727	FDA 510(k)	Class II	Active
Density	K230663	FDA 510(k)	Class II	Active
Potenza	16	EUDAMEDFDA UDI	Class IIb	Active
LIPOcel	11	EUDAMED	Class IIb	Active
Sonotrip V20	17	EUDAMED	Class IIb	Active

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