Data / Medical devices / South Korea / Lameditech Co., Ltd.
Lameditech Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 1 510(k) clearance
Lameditech Co., Ltd. is registered with the FDA (registration 3014384451) in Seoul, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 7, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014384451
- Address
- #1002, ACE High End Tower 6th, Beotkkot-ro-234, Geumcheon-gu, Seoul, South Korea, 08513
- Owner or operator
- LAMEDITECH Co., Ltd. (10057401)
- Roles
- Manufacturer
- First device listed
- March 29, 2018
- Registered through
- 2026
- Brand names listed
- HandyRay (model LMT-3000), HandyRay-Lite (model LMT-1000), HandyRay-Pro (model LMT-5000)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 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 |
|---|---|---|---|---|---|---|
| March 7, 2018 | K172818 | LMT-3000 | GEX | Substantially Equivalent | Lameditech Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 7, 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.