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Vitra 810

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K201502

by Quantel Medical

Identifiers

510(k) Number
K201502 FDA 510(k)
FDA Product Code
HQF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.4390 FDA 510(k)
Regulation Number
886.4390 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vitra 810 is an ophthalmic laser device designed for precise retinal procedures. Classified as a Class II medical device under FDA regulations, it is intended for use in laser treatments of the eye, including photocoagulation and other retinal interventions.

This system is supplied as a reusable medical device and is regulated under the FDA’s 510(k) clearance and the European Medical Device Directive (MDD). It is intended for use in clinical settings, such as ophthalmology clinics or hospitals, and requires proper training for operation. The device is not single-use and must be maintained according to manufacturer guidelines to ensure safety and efficacy.

Frequently asked questions

Is the Vitra 810 designed for single-use or can it be reused in clinical settings?

The Vitra 810 is explicitly described as a reusable medical device. Since it is intended for clinical use in ophthalmology, it must be maintained according to the manufacturer’s guidelines to ensure safety and efficacy during repeated procedures. Reusability is a key factor in its design and regulatory classification as a Class II device.

What types of retinal procedures is the Vitra 810 intended to assist with, and how does it achieve precision?

The Vitra 810 is designed for ophthalmic laser treatments, specifically photocoagulation and other retinal interventions. Its precision comes from its classification as an ophthalmic laser device, which implies controlled energy delivery for targeted retinal procedures. The device is regulated under FDA’s 510(k) pathway, indicating it meets standards for safety and effectiveness in these specialized applications.

How is the Vitra 810 regulated in the U.S. and Europe, and what does that mean for purchasing or using it?

The Vitra 810 holds FDA 510(k) clearance (traditional pathway, substantially equivalent) and complies with the European Medical Device Directive (MDD). This means it has undergone review by regulatory authorities to confirm its safety and performance for intended use in laser retinal procedures. Purchasers or users should ensure compliance with local regulations, including proper training for operation, as the device is intended for clinical settings like ophthalmology clinics or hospitals.

Are there different models or sizes available for the Vitra 810, and if so, how might they differ?

The provided data does not specify distinct models or sizes for the Vitra 810. However, as an ophthalmic laser device, variations in wavelength, power settings, or application accessories (e.g., lenses or handpieces) may exist to accommodate different retinal procedures. For precise details, consulting the manufacturer’s technical documentation or contacting Quantel Medical would be necessary, as these features are not explicitly listed in the regulatory submission.

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.

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) K201502 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026