Vision One Laser System
FDA 510(k)Class II (US FDA 510(k))
by Lumenis Inc.
Identifiers
- 510(k) Number
- K111213 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 Vision One Laser System is a photocoagulation laser device designed for retinal procedures, delivering controlled laser energy to treat ocular conditions. It operates across multiple wavelengths—red (659 nm), yellow (577 nm), and green (532 nm)—to perform selective photocoagulation, including panretinal and focal treatments. This modular system is classified under Product Code GEX and is intended for use in ophthalmic settings where precise laser therapy is required. Its design supports customizable settings and dual-port configurations for procedural efficiency.
The system is supplied as a reusable medical device, intended for use in clinical environments such as ophthalmology clinics or hospitals. It is not described as sterile but requires adherence to standard infection control protocols for reusable equipment. The device’s regulatory status includes FDA 510(k) clearance (K111213) under the Special 510(k) Review Program, with a decision date of July 25, 2011. No MRI safety or single-use specifications are noted in the available data.
Frequently asked questions
What retinal conditions is the Vision One Laser System designed to treat?
The Vision One Laser System is specifically designed for retinal photocoagulation procedures, including panretinal and focal treatments. It uses controlled laser energy at three distinct wavelengths—red (659 nm), yellow (577 nm), and green (532 nm)—to target and treat ocular conditions such as diabetic retinopathy, retinal vein occlusion, or retinal tears. The modular and customizable settings allow clinicians to tailor the laser application to the precise needs of each procedure.
How is the Vision One Laser System supplied and what are its infection control requirements?
The Vision One Laser System is supplied as a reusable medical device, intended for use in clinical environments like ophthalmology clinics or hospitals. Since it is not sterile, it must be cleaned and maintained according to standard infection control protocols for reusable equipment. This includes proper disinfection between uses and adherence to manufacturer guidelines to ensure safety and functionality.
Is the Vision One Laser System single-use or reusable, and what does that mean for its maintenance?
The Vision One Laser System is a reusable device, meaning it is designed for repeated use in clinical settings after proper cleaning, disinfection, and maintenance. Unlike single-use devices, reusable systems require regular servicing, calibration, and adherence to manufacturer instructions to ensure consistent performance and safety. This includes periodic inspections to verify the integrity of components like the laser source and optical pathways.
What are the key distinguishing features of the Vision One Laser System’s modular design?
The Vision One Laser System’s modular design allows for flexibility in procedural workflows by supporting customizable settings and dual-port configurations. This means clinicians can adapt the system to different treatment requirements, such as adjusting laser parameters or switching between ports for efficiency. The modularity also facilitates easier maintenance and upgrades, as components can be replaced or updated without replacing the entire system.
What regulatory pathway does the Vision One Laser System follow, and what does that mean for its use?
The Vision One Laser System has received FDA 510(k) clearance under the Special 510(k) Review Program, with a clearance number of K111213. This pathway confirms that the device is substantially equivalent to a legally marketed predicate device and meets FDA safety and effectiveness requirements. Clinicians can rely on this clearance to ensure the system adheres to regulatory standards for photocoagulation laser devices in ophthalmic applications.
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: Vision One Photocoagulation Laser from Lumenis Vision, Retinal Laser Photocoagulation | Lumenis, Vision One Laser System | Lumenis UK, Lumenis Vision One - SCL Company SA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111213 | Class II | Active |
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Manufacturer
- Manufacturer
- Lumenis Inc.
- FDA Applicant
- Lumenis, Inc.
Sources (1)
- FDA 510(k) K111213 24 fields · synced Oct 1, 2026