Data / Medical devices / Israel / G.N.S Neolaser Ltd.
G.N.S Neolaser Ltd.: FDA-registered device maker in Caesarea Central, Israel, 2 510(k) clearances
G.N.S Neolaser Ltd. is registered with the FDA (registration 3011514163) in Caesarea Central, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011514163
- Address
- 7 HaEshel St PO BOX 3203, Caesarea Central, Israel, 38900
- Owner or operator
- G.N.S neoLaser Ltd. (10048512)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 21, 2015
- Registered through
- 2026
- Brand names listed
- neoV1064, neoV1470, neoV810, neoV980
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, 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 13, 2025 | K250113 | neoLaser Laser Surgery Fibers | GEX | Substantially Equivalent | G.N.S Neolaser , Ltd. | accessdata.fda.gov |
| April 17, 2014 | K133006 | NEOV DIODE LASER FAMILY | GEX | Substantially Equivalent | G.N.S Neolaser , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 13, 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.