GA-2000011GR, GA-2000021GR

Organization name

Lumenis (Germany) GmbH

SRN

DE-MF-000007655

Manufacturer status

Active

8 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW273

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• CW167

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• CW013

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• CW016

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• CW169

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• CW007

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• CW275

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Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04260539181557

Basic UDI-DI

426053918UPAJ7

Reference / catalog number

GA-2000011GR, GA-2000021GR

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The UltraPulse Alpha is an advanced computer‑controlled CO₂ laser platform based on a sealed‑off radiofrequency (RF)‑modulated CO₂ laser tube, operating at a wavelength of 10,600 nm. The system delivers laser energy through a free beam port connected to a articulated arm and compatible delivery devices, including handpieces and scanners. The device supports both UltraPulse (UP) and Continuous Wave (CW) laser delivery modes, which may be used in single, repeat or continuous timed‑exposure modes to enable controlled tissue interaction. The system provides adjustable laser output power up to 60 W and generates short‑duration, high‑peak‑power pulses for rapid tissue vaporization with minimal thermal conduction to adjacent tissue. Scanning capabilities are available when used with compatible accessories, enabling delivery of laser energy in predefined pattern shapes and densities. The UltraPulse Alpha platform includes proprietary embedded software with touchscreen graphical user interface (GUI) for selection of treatment parameters including energy, power, frequency and laser delivery mode. The system incorporates an integrated cooling system, internal purge air unit and diode‑based red aiming beam aligned with the treatment beam for visual targeting.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12011005CARBON DIOXIDE SURGICAL LASER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification