Data / Medical devices / United States / IR Technology, LLC
IR Technology, LLC: FDA-registered device maker in Woodstock, GA, United States, 1 510(k) clearance
IR Technology, LLC is registered with the FDA (registration 3014278036) in Woodstock, GA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 19, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014278036
- Address
- 2707 Hampton TRL, Woodstock, GA, United States, 30189
- Owner or operator
- IR Technology LLC (10056964)
- Roles
- Specification developer
- First device listed
- July 14, 2022
- Registered through
- 2026
- Brand names listed
- invisa-RED ELITE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fat Reducing Low Level Laser | OLI | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 19, 2020 | K192275 | invisa-RED ELITE | OLI | Substantially Equivalent | IR Technology, LLC | accessdata.fda.gov |
Compare with other makers
Updated August 19, 2020. 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.