Light Guide Optics International , Ltd.
Latvia LV-MF-000009236 Last updated 22 Oct 2026
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- Devices
- 13
- Registries
- EUDAMEDFDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Infinity Fiber Irh 400 1.3 Fused Ref SFCS000522
AMI-Infinity Side Fire Fiber 600 1.6 Ref SFCS000473
Infinity Side Fire Fiber IRH 600 1.8 Fused Ref SFCS000359
AMI-Saturn Slight Side Fiber 400 1.0 Glued Ref SFCS000526
AMI-Saturn Side Fiber IRH 600 1.8 Ref SFCS000487
LGO-Bare Fiber HIR 200 T Ref BFF000046
AMI-Saturn Side Fiber IRH 600 1.6 Ref SFCS000475
intros Infinity Side Fire Fiber GR_P 600 1.8 Fused Ref SFCS000372
Radial Fiber Irh 600 1.8 Fused Ref SFCS000424
AMI-Saturn Slight IRH 400 1.3 Fused Ref SFCS000479
intros lipo fiber 600 Ref BFCS000379
AMI-Infinity Side Fire Fiber IRH 600 1.8 Ref SFCS000467
LGO-Surgical Laser Fibers Ref K243147
EUDAMED certificates
Notified body 0044 1 certificate
- 44911230624 Issued
Quality management system EU MDR
- Issued
- 12 Aug 2026
- Expires
- 11 Aug 2031
Related companies
Notified bodies
- Notified body 0044
FDA establishments
- Light Guide Optics International Ltd. Livani Preilu Novads · LV FEI 3012669557
What Light Guide Optics International , Ltd. makes
Light Guide Optics International, Ltd. manufactures surgical laser fibers designed for use in medical laser procedures, providing precise light delivery in surgical applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Light Guide Optics International, Ltd. manufacture?
Light Guide Optics International, Ltd. specializes in manufacturing surgical laser fibers. These fibers are used to deliver laser energy with precision during medical laser procedures, ensuring controlled light transmission in surgical settings.
Where is Light Guide Optics International, Ltd. based?
The company is headquartered in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs the classification and authorization of its devices.
How are the devices manufactured by Light Guide Optics International, Ltd. classified under FDA regulations?
The surgical laser fibers produced by Light Guide Optics International, Ltd. fall under Class II classification according to FDA guidelines. This classification is typically assigned to devices that pose minimal potential risk but still require general controls to ensure safety and effectiveness.
Which regulatory registries or pathways are used to list the devices made by Light Guide Optics International, Ltd.?
The company’s devices are listed via the FDA’s 510(k) pathway, a premarket submission required for most Class II devices. This process demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA requirements.
Information
- Country
- Latvia
- Address
- 8, Celtniecibas , Livani, Latvia
- Website
- www.lightguide.com/
- [email protected]
- Phone
- +37165307175
- PRRC contact
- Santa Vucina
- EUDAMED SRN
- LV-MF-000009236