105 403 010

Nom de l'organisation

LISA Laser Products GmbH

SRN

DE-MF-000005036

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW010

  EUDAMED n'a pas publié de description pour ce code.

Marché principal en Allemagne ; disponible dans 4 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

04250341911862

Basic UDI-DI

B-04250341911862

Numéro de référence/catalogue

105 403 010

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

RevoLix HTL laser device is a Thulium:YAG laser emitting radiation of 2013 nm (±10 nm) inwavelength. This wavelength is in the invisible infrared range.The RevoLix HTL laser device offers a combination of two operating modes. In the continuous-wave (CW)operation mode, laser radiation is emitted continuously. The CW mode is used for soft tissue indications.In PULSED mode, laser pulses are emitted at an adjustable frequency. The peak power of these individualpulses is higher than their average power over the same time interval. The PULSED mode is used for laserlithotripsy.The laser radiation is transmitted through a fibre made of quartz glass, and its distal end is connected to asuitable applicator. Various applicators are available and tailored to serve specific clinical applications.The laser device is operated via a control console equipped with a screen. Laser radiation can be emittedby pressing a foot pedal of a footswitch.RevoLix HTL laser devices comply with the "General Safety and Performance Requirements" of theRegulation (EU) 2017/745 on Medical Devices.

URL des informations complémentaires

https://www.omni-guide.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12011006DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER

• Numéro de lot
• Date d'expiration
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