Data / Medical devices / South Korea / Lutronic Corporation
Lutronic Corporation: FDA-registered device maker in Daegu Gyeongbuk, South Korea, 3 510(k) clearances
Lutronic Corporation is registered with the FDA (registration 3023706404) in Daegu Gyeongbuk, South Korea. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 10, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023706404
- Address
- 56 Cheombok-ro, Dong-gu, Daegu Gyeongbuk, South Korea, 41069
- Owner or operator
- Lutronic Aesthetics, Inc. (9058403)
- Roles
- Manufacturer
- First device listed
- January 14, 2013
- Registered through
- 2026
- Brand names listed
- HEALITE II, INIFINI, LUTRONIC GENIUS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 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 |
|---|---|---|---|---|---|---|
| December 10, 2018 | K180945 | LUTRONIC GENIUS Radiofrequency System | GEI | Substantially Equivalent | Lutronic Corporation | accessdata.fda.gov |
| June 25, 2013 | K121481 | INFINI RADIOFREQUENCY SYSTEM | GEI | Substantially Equivalent | Lutronic Corporation | accessdata.fda.gov |
| June 19, 2012 | K113668 | HEALITE II SYSTEM | ILY | Substantially Equivalent | Lutronic Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated December 10, 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.