105 403 010

Organization name

LISA Laser Products GmbH

SRN

DE-MF-000005036

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 4 countries total.

Trade name

not provided

UDI-DI code

04250341911862

Basic UDI-DI

B-04250341911862

Reference / catalog number

105 403 010

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

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

Clinical sizes

No clinical sizes registered for this device.

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

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