Data / Medical devices / Israel / XPLR Ltd.
XPLR Ltd.: FDA-registered device maker in Yehud Tel Aviv, Israel, 1 510(k) clearance
XPLR Ltd. is registered with the FDA (registration 3042970900) in Yehud Tel Aviv, Israel. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042970900
- Address
- Ben ami 6 st, Yehud Tel Aviv, Israel, 5647867
- Owner or operator
- XPLR Ltd. (10094734)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 18, 2025
- Registered through
- 2026
- Brand names listed
- LMNT O2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 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 |
|---|---|---|---|---|---|---|
| March 24, 2025 | K250125 | LMNT O2 | OHS | Substantially Equivalent | Xplr , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
Updated March 24, 2025. 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.