Data / Medical devices / South Korea / FINEMEC Co., Ltd
FINEMEC Co., Ltd: FDA-registered device maker in Gangseo-gu Seoul, South Korea, 2 510(k) clearances
FINEMEC Co., Ltd is registered with the FDA (registration 3012440264) in Gangseo-gu Seoul, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 30, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012440264
- Address
- 604-1, 217, Heojun-Ro, Gangseo-gu Seoul, South Korea, 147793
- Owner or operator
- FineMEC Co., Ltd. (10050037)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 6, 2015
- Registered through
- 2026
- Brand names listed
- Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System, Noblex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| November 30, 2018 | K182663 | Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System | GEX | Substantially Equivalent | Finemec Co., Ltd. | accessdata.fda.gov |
| April 23, 2015 | K143666 | Noblex Long Pulse Alexandrite Laser | GEX | Substantially Equivalent | Finemec Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 30, 2018. 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.