Data / Medical devices / Israel / LIGHT INSTRUMENTS Ltd.
LIGHT INSTRUMENTS Ltd.: FDA-registered device maker in Yokneam Northern, Israel, 2 510(k) clearances
LIGHT INSTRUMENTS Ltd. is registered with the FDA (registration 3005801723) in Yokneam Northern, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 23, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005801723
- Address
- 4 Hatnufa Street Yokneam, Yokneam Northern, Israel, 2066717
- Owner or operator
- LIGHT INSTRUMENTS Ltd. (9089640)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 13, 2006
- Registered through
- 2026
- Brand names listed
- D-STORM, Lite Touch, LT System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Exporter to the US, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 23, 2010 | K093048 | D-STORM 810NM, D-STORM 980NM | GEX | Substantially Equivalent | Light Instruments | accessdata.fda.gov |
| September 27, 2006 | K061966 | LITETOUCH DENTAL LASER SYSTEM | GEX | Substantially Equivalent | Light Instrument, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 23, 2010. 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.