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Sign in to claim this brandAGNES MEDICAL CO., LTD.
US
Last updated May 30, 2026
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
- US
- Address
- —
- Website
- agnesmedical.com
- —
- —
- [email protected]
- Phone
- +823180209717
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 695070346
Catalogue (28)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ga-I | GA-I | FDA UDI | Class II | Active |
| Ag-Cn19g | AG-CN19G | FDA UDI | Class II | Active |
| Ag-Cn23g | AG-CN23G | FDA UDI | Class II | Active |
| Ga-Il | GA-IL | FDA UDI | Class II | Active |
| Ga-E | GA-E | FDA UDI | Class II | Active |
| Ag-Cn20g | AG-CN20G | FDA UDI | Class II | Active |
| Agnes | AGNES | FDA UDI | Class II | Active |
| Ga-F1a | GA-F1A | FDA UDI | Class II | Active |
| Ga-C | GA-C | FDA UDI | Class II | Active |
| Ag-Cn21g | AG-CN21G | FDA UDI | Class II | Active |
| Ag-Cn18g | AG-CN18G | FDA UDI | Class II | Active |
| Ga-S | GA-S | FDA UDI | Class II | Active |
| Ga-F3a | GA-F3A | FDA UDI | Class II | Active |
| Ga-F1b | GA-F1B | FDA UDI | Class II | Active |
| Ga-B | GA-B | FDA UDI | Class II | Active |
| Ga-W3b | GA-W3B | FDA UDI | Class II | Active |
| Agnes | AGNES | FDA UDI | Class II | Active |
| Ga-W3a | GA-W3A | FDA UDI | Class II | Active |
| Agnes-S | AGNES-S | FDA UDI | Class I | Active |
| Agnes-S | AGNES-S | FDA UDI | Class II | Active |
| Ga-Sl | GA-SL | FDA UDI | Class II | Active |
| Agnes | K203013 | FDA 510(k) | Class II | Active |
| PlazMagik | K230837 | FDA 510(k) | Class II | Active |
| RFMagik Lite | K242469 | FDA 510(k) | Class II | Active |
| Agnes | K223805 | FDA 510(k) | Class II | 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) | K243713 | FDA 510(k) | Class II | Active |
| Agnes | K192728 | FDA 510(k) | Class II | Active |
| AGNES Ultra | K250217 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Agnes Medical Co., Ltd Seongnam-si Gyeonggi · KR FEI 3010164891