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AGNES MEDICAL CO., LTD.

KR Last updated 22 Oct 2026

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Devices
50
Registries
GUDIDFDA 510(k)FDA
FDA recalls
0

Catalogue50

  • PlazMagik Ref PlazMagik

    Class II FDA UDI Active

  • Ro-25S Ref RO-25S

    Class II FDA UDI Active

  • Ro-25D Ref RO-25D

    Class II FDA UDI Active

  • Ro-25S(G) Ref RO-25S(G)

    Class II FDA UDI Active

  • Ro-25D(G) Ref RO-25D(G)

    Class II FDA UDI Active

  • An-E Ref AN-E

    Class II FDA UDI Active

  • An-B Ref AN-B

    Class II FDA UDI Active

  • An-C Ref AN-C

    Class II FDA UDI Active

  • Agnes Ultra Ref AGNES ULTRA

    Class II FDA UDI Active

  • Ros-25S(G) Ref ROS-25S(G)

    Class II FDA UDI Active

  • Ros-25D(G) Ref ROS-25D(G)

    Class II FDA UDI Active

  • An-S Ref AN-S

    Class II FDA UDI Active

  • An-I Ref AN-I

    Class II FDA UDI Active

  • An-F3A Ref AN-F3A

    Class II FDA UDI Active

  • An-W3A Ref AN-W3A

    Class II FDA UDI Active

  • An-Sl Ref AN-SL

    Class II FDA UDI Active

  • An-Il Ref AN-IL

    Class II FDA UDI Active

  • An-F3B Ref AN-F3B

    Class II FDA UDI Active

  • An-W3B Ref AN-W3B

    Class II FDA UDI Active

  • An-B3A Ref AN-B3A

    Class II FDA UDI Active

  • An-B4A Ref AN-B4A

    Class II FDA UDI Active

  • An-F1B Ref AN-F1B

    Class II FDA UDI Active

  • Ga-I Ref GA-I

    Class II FDA UDI Active

  • AG-CN19G Ref AG-CN19G

    Class II FDA UDI Active

  • AG-CN23G Ref AG-CN23G

    Class II FDA UDI Active

  • Ga-Il Ref GA-IL

    Class II FDA UDI Active

  • Ga-E Ref GA-E

    Class II FDA UDI Active

  • AG-CN20G Ref AG-CN20G

    Class II FDA UDI Active

  • Agnes Ref AGNES

    Class II FDA UDI Active

  • Ga-F1A Ref GA-F1A

    Class II FDA UDI Active

  • Ga-C Ref GA-C

    Class II FDA UDI Active

  • AG-CN21G Ref AG-CN21G

    Class II FDA UDI Active

  • AG-CN18G Ref AG-CN18G

    Class II FDA UDI Active

  • Ga-S Ref GA-S

    Class II FDA UDI Active

  • Ga-F3A Ref GA-F3A

    Class II FDA UDI Active

  • Ga-F1B Ref GA-F1B

    Class II FDA UDI Active

  • Ga-B Ref GA-B

    Class II FDA UDI Active

  • Ga-W3B Ref GA-W3B

    Class II FDA UDI Active

  • Agnes Ref AGNES

    Class II FDA UDI Active

  • Ga-W3A Ref GA-W3A

    Class II FDA UDI Active

  • Agnes-S Ref AGNES-S

    Class I FDA UDI Active

  • Agnes-S Ref AGNES-S

    Class II FDA UDI Active

  • Ga-Sl Ref GA-SL

    Class II FDA UDI Active

  • Agnes Ref K203013

    Class II FDA 510(k) Active

  • PlazMagik Ref K230837

    Class II FDA 510(k) Active

  • RFMagik Lite Ref K242469

    Class II FDA 510(k) Active

  • Agnes Ref K223805

    Class II FDA 510(k) Active

  • Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) Ref K243713

    Class II FDA 510(k) Active

  • Agnes Ref K192728

    Class II FDA 510(k) Active

  • AGNES Ultra Ref K250217

    Class II FDA 510(k) Active

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Agnes Medical Co., Ltd Seongnam-si Gyeonggi · KR FEI 3010164891

What AGNES MEDICAL CO., LTD. makes

AGNES Medical Co., Ltd. manufactures intradermal radio-frequency ablation systems, including both standalone devices and needle electrode attachments designed for precise tissue treatment. Their portfolio includes models like the GA-I, AG-CN series, and GA-IL, which are intended for controlled energy delivery in medical procedures. These systems are engineered for procedures requiring localized tissue modification or coagulation.

The company’s devices are regulated under FDA classifications, with products falling into Class I and Class II categories. They appear in the FDA’s 510(k) and UDI registries, indicating compliance with U.S. medical device authorization requirements. The manufacturer is based in the United States.

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

Frequently asked questions

What types of medical devices does AGNES Medical Co., Ltd. primarily manufacture?

AGNES Medical Co., Ltd. specializes in intradermal radio-frequency ablation systems. These include standalone devices like the GA-I and GA-IL, as well as needle electrode attachments (e.g., AG-CN18G, AG-CN23G) designed to deliver controlled radio-frequency energy for precise tissue treatment or coagulation. The focus is on procedures requiring localized energy application.

Where is AGNES Medical Co., Ltd. based, and how does that affect its regulatory standing?

AGNES Medical Co., Ltd. is based in the United States, which means its devices are subject to U.S. regulatory requirements. The company’s products are listed in the FDA’s 510(k) and UDI registries, reflecting compliance with U.S. authorization processes for medical devices. This ensures transparency and adherence to U.S. standards for device safety and performance.

Which regulatory registries list AGNES Medical Co., Ltd.’s devices, and why does this matter?

AGNES Medical Co., Ltd.’s devices appear in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process demonstrates that the devices meet regulatory standards for safety and effectiveness by showing substantial equivalence to legally marketed predicates. The UDI registry ensures traceability and clarity in tracking devices throughout their lifecycle, which is critical for healthcare providers and regulators.

How are AGNES Medical Co., Ltd.’s devices classified under FDA regulations, and what does this classification indicate?

AGNES Medical Co., Ltd.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or post-market surveillance due to moderate risk. The classification reflects the level of oversight required to ensure the device’s safety and effectiveness, with Class II devices typically undergoing more rigorous review.

What does it mean for AGNES Medical Co., Ltd.’s devices to be listed in the FDA’s 510(k) registry?

Listing in the FDA’s 510(k) registry indicates that AGNES Medical Co., Ltd.’s devices have undergone a premarket notification process to demonstrate they are substantially equivalent to legally marketed devices already on the market. This means the FDA has reviewed the device’s design, intended use, and safety data to confirm it meets regulatory requirements without requiring a full approval process. It’s a key step in ensuring the device complies with U.S. medical device regulations.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
KR
Phone
+823180209717
DUNS number
695070346