Data / Medical devices / Latvia / Light Guide Optics International Ltd.
Light Guide Optics International Ltd.: FDA-registered device maker in Livani Preilu Novads, Latvia, 1 510(k) clearance
Light Guide Optics International Ltd. is registered with the FDA (registration 3012669557) in Livani Preilu Novads, Latvia. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012669557
- Address
- Celtniecibas street 8, Livani Preilu Novads, Latvia, LV 5316
- Owner or operator
- Light Guide Optics International Ltd. (10050996)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 25, 2016
- Registered through
- 2026
- Brand names listed
- 0.9 mm Auryon" Atherectomy Catheter without aspiration, 0.9 mm OTW B-Laser catheter, 0.9mm RX catheter (Hydrophilic), 0.9mm RX catheter (non coated), 1.5 mm Auryon" Atherectomy Catheter without aspiration, 1.5 mm OTW B-Laser catheter, 1.5mm RX catheter (Hydrophilic), 1.5mm RX catheter (non coated) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Peripheral, Atherectomy | MCW | 2 | Contract manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer, 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 21, 2024 | K243147 | LGO-Surgical Laser Fibers | GEX | Substantially Equivalent | Light Guide Optics International , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 21, 2024. 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.