FDA.reportPublic FDA data

VITRA MULTISPOT

Primary DI
03700542625415
Brand
VITRA MULTISPOT
Company
QUANTEL MEDICAL
Model
VMS
Device description
532nm Multispot LaserRetinal Photocoagulation
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700542625415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700542625415037005426254153700542625415

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic solid-state laser system, photocoagulation/photostimulationAn electrically-powered device assembly with a solid-state laser (exited glass/crystal rod), that might be designed to optionally utilize the diode pump laser as a direct therapeutic laser, intended for: 1) ocular photocoagulation-based procedures (e.g., coagulate abnormal vascular tissue in the retina); and/or 2) dosimetery-controlled photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration; it might additionally be intended for iridectomy. It may include a built-in slit lamp and a dosimetry sensor, however, it does not include femtosecond pulsing or fundus imaging technology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33(0)473745745contact@quantel-medical.fr

Regulatory Flags#

DUNS number
738574953
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700542625958CAPSULOCAPSULO2025-03-25
03700542626009POCKET IIIPOCKET III2025-03-25
03700542625316SUPRA 577YSUPRA 577Y2016-09-23
03700542625941AXIALISAXIALIS2022-01-05
03700542625569VITRA 2 VITRA 2 2021-12-29
03700542625613VITRA 810VITRA 8102021-12-29
03700542625927EASYRETEASYRET2021-10-19
03700542625132VITRAVITRA2016-09-23
03700542625286SUPRASUPRA2016-09-23
03700542625484EASYRETEASYRET2017-09-11
03700542625224532nm Heine Omega IO with integrated adaptorIOH8105322016-09-23
03700542625231532nm adaptor for Keeler Vantage Plus IO (100µ)810532IOVPST2016-09-23
03700542625248Keeler Vantage Plus IOLAFVP22016-12-07
03700542625392577nm Heine Omega 500 IO with integrated adaptorIOH5772016-09-23
03700542625408577nm adaptor for Keeler Vantage Plus IO (100µ)577IOV1002016-09-23
03700542625521ABSOLUABSOLU2019-07-09
03700542625002AVISO (S)AVISO (S)2016-09-23
03700542625057B Probe 10MHz AVISOB1 AVISO2016-09-23
03700542625064B Probe 20MHz AVISOB-HF AVISO2016-09-23
03700542625118A Standardized ProbeStd-A2016-09-23

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