Data / Medical devices / South Korea / Amt Engineering Co., Ltd.
Amt Engineering Co., Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 4 510(k) clearances
Amt Engineering Co., Ltd. is registered with the FDA (registration 3010902869) in Seongnam-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 6, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010902869
- Address
- #811 Byoksan Technopia 560 Dunchon-daero, Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13230
- Owner or operator
- AMT Engineering Co., Ltd. (10047063)
- Roles
- Manufacturer
- First device listed
- June 20, 2014
- Registered through
- 2027
- Brand names listed
- ATONE, COPRO 3, Lucas Plus, Olive Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 6, 2024 | K241672 | COPRO 3 | GEX | Substantially Equivalent | Amt Engineering Co., Ltd. | accessdata.fda.gov |
| May 4, 2023 | K230340 | Lucas Plus | GEX | Substantially Equivalent | Amt Engineering Co., Ltd. | accessdata.fda.gov |
| October 14, 2016 | K161981 | Olive Plus | GEX | Substantially Equivalent | Ama Network, Inc. | accessdata.fda.gov |
| May 30, 2014 | K131712 | A-TONE IPL SYSTEM | ONF | Substantially Equivalent | Ybk Investment, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
- All makers of Powered Laser Surgical Instrument
Updated September 6, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.