Vitra 2

Quantel Medical

Country / region:France (FR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

France (FR)

Product code

GEX
21 CFR 878.4810

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1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K191962
Device name
Vitra 2
Country / region
France(FR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-07-23
Decision date
2019-12-05
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
OphthalmicVascular treatmentOther
Primary application
Ophthalmic
Classification source
AI classified

Indications for Use

The Vitra 2 is for use in the treatment of ocular pathology of anterior and posterior segments including retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroids including:
• Proliferative and nonproliferative diabetic retinopathy
• Choroidal neovascularization
• Branch retinal vein occlusion
• Treatment of choroidal neovascularization associated with wet Age-related macular degeneration
• Retinal tears and detachments
• Macular edema

Intended Use

The Vitra 2 is for use in the treatment of ocular pathology of anterior and posterior segments including retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroids including: • Proliferative and nonproliferative diabetic retinopathy • Choroidal neovascularization • Branch retinal vein occlusion • Treatment of choroidal neovascularization associated with wet Age-related macular degeneration • Retinal tears and detachments • Macular edema

Device Description

The Vitra 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. Laser energy is delivered to opaque structures within the eye by means of delivery systems including slit lamp, indirect ophthalmoscope, operating microscope and endocular probe. The standard delivery system includes a lens system to focus the laser energy and vary the size of the laser spot in the plane of observation of the slit lamp, for example. It also includes a Multispot delivery system made by scanner motors which can deliver several spots to the retina in a pattern. The laser energy is delivered to the delivery system by the means of a flexible fiber optic. For most procedures, a laser contact lens is used to direct the laser energy to the part of the eye being treated. The contact lens also helps to hold the eye open and still so that the laser energy can be delivered effectively. The Quantel Medical VITRA 2 includes a Scanning Laser Delivery System adaptor with scanner controls that may be coupled to a slit lamp. Once activated by the user, the VITRA 2 delivers a predetermined pattern by sequentially scanning the placement of the laser spots and the emission of the individual pulses of laser light. Treatment is initiated by pressing the footswitch and may be aborted by releasing the footswitch.

Summary parsed at:2026-06-01 05:55:43 UTC

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