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Vitra 2

by Quantel Medical

510(k) K191962

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK191962 Date5 Dec 2019ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191962 decided 5 Dec 2019 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
GEX
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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).

Devices cleared under K191962

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K191962
UDI-DISize and differences
VITRA 2
QUANTEL MEDICAL
VITRA 203700542625569 —On the market

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Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

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