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Vitra 2

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K191962

by Quantel Medical

Identifiers

510(k) Number
K191962 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 Vitra 2 is a retinal photocoagulation laser designed for ophthalmic use. It delivers precise laser treatment to the retina, primarily for managing conditions such as diabetic retinopathy, age-related macular degeneration, and retinal vascular abnormalities. This device operates at a wavelength of 532 nm, enabling targeted photocoagulation with controlled energy delivery. Its classification aligns with ophthalmic laser systems used in surgical and therapeutic retinal interventions.

The Vitra 2 is supplied as a standalone system compatible with Haag-Streit and Zeiss slit lamps, facilitating integration into existing ophthalmic examination setups. It is intended for use in clinical environments, including outpatient clinics and hospital ophthalmology departments, where retinal procedures are performed. The device is not described as single-use or reusable in the specifications, though its sterility and maintenance protocols would follow standard clinical laser device guidelines. No explicit MRI safety information is provided, and its regulatory authorisations include FDA 510(k) clearance under the General, Plastic Surgery advisory committee and compliance with the MDD (Medical Device Directive).

Frequently asked questions

What clinical conditions is the Vitra 2 retinal photocoagulation laser primarily used to treat?

The Vitra 2 is designed for managing retinal conditions such as diabetic retinopathy, age-related macular degeneration, and retinal vascular abnormalities. Its 532 nm wavelength allows precise photocoagulation to target and stabilize damaged retinal tissue, helping to preserve vision in these progressive diseases.

How does the Vitra 2 integrate with existing ophthalmic examination equipment?

The Vitra 2 is a standalone system that is compatible with both Haag-Streit and Zeiss slit lamps, making it easy to integrate into current clinical setups without requiring additional infrastructure. This compatibility ensures seamless use in outpatient clinics or hospital ophthalmology departments.

Is the Vitra 2 intended for single-use or repeated use in clinical settings?

The device’s specifications do not explicitly state whether it is single-use or reusable. However, like most clinical laser systems, its sterility and maintenance would follow standard protocols to ensure safe, repeated use in controlled environments such as ophthalmology departments.

What regulatory pathways has the Vitra 2 followed for market authorization?

The Vitra 2 holds FDA 510(k) clearance under the General, Plastic Surgery advisory committee (reviewed by the Ophthalmic Devices Panel) and complies with the Medical Device Directive (MDD). Its clearance was determined as substantially equivalent to a predicate device, enabling its commercial distribution in the U.S. and EU markets.

Does the Vitra 2 have any known limitations regarding use in environments with MRI machines?

The provided specifications do not include explicit MRI safety information for the Vitra 2. Clinicians should consult manufacturer guidelines or technical documentation to ensure safe operation in proximity to MRI equipment, as laser systems may pose risks in electromagnetic environments.

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: Lumibird Quantel Medical VITRA 2® Retinal Photocoagulation Laser, Retinal photocoagulation laser - VITRA 2 - Quantel Medical ..., Vitra 2 532nm - Top Ophthalmic Products & Services Corp., VITRA 2 532nm Retinal Photocoagulation from Quantel Medical

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Quantel Medical

Sources (2)

  • FDA 510(k) K191962 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026