Smart Laser Indirect Ophthalmoscope (LIO) +1 more model
FDA 510(k)Class II (US FDA 510(k))
by Lumenis Inc.
Identifiers
- 510(k) Number
- K162837 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Smart Laser Indirect Ophthalmoscope (LIO) is a laser delivery device designed for use in ophthalmic photocoagulation procedures. It is intended to work in conjunction with the Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System.
The device is supplied as part of a laser delivery system for retinal treatment and is used in clinical settings such as operating rooms and outpatient clinics. It has received FDA 510(k) clearance under K162837 with product code GEX and is classified as substantially equivalent to a predicate device.
Frequently asked questions
What is the Smart Laser Indirect Ophthalmoscope (LIO) used for?
The Smart Laser Indirect Ophthalmoscope (LIO) is a laser delivery device designed for use in ophthalmic photocoagulation procedures, specifically for retinal treatment, and is intended to work with compatible Lumenis laser systems to deliver laser energy during clinical interventions.
Which laser systems is the Smart Laser Indirect Ophthalmoscope (LIO) compatible with?
The Smart Laser Indirect Ophthalmoscope (LIO) is designed to work in conjunction with the Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System, as specified in its device description and intended use.
Is the Smart Laser Indirect Ophthalmoscope (LIO) supplied as a standalone device or as part of a system?
The device is supplied as part of a laser delivery system for retinal treatment, meaning it is not sold as a standalone component but is intended to be used integrated with the specified Lumenis laser systems in clinical environments such as operating rooms and outpatient clinics.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Laser Indirect Ophthalmoscopes | Lumenis, Novus Spectra - photocoagulation Laser System | Lumenis, Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for ..., Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162837 | Class II | Active |
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Manufacturer
- Manufacturer
- Lumenis Inc.
- FDA Applicant
- Lumenis, Ltd.
Sources (1)
- FDA 510(k) K162837 24 fields · synced Oct 1, 2026