SA-1146410BeGR , SPSA-1146410BeGR

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

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.
• CW016

  EUDAMED did not publish a description for this code.
• CW013

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW275

  EUDAMED did not publish a description for this code.
• CW169

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04260539181168

Basic UDI-DI

426053918RFXHPDG

Reference / catalog number

SA-1146410BeGR , SPSA-1146410BeGR

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 ResurFX™ is a detachable laser module for the Stellar M22 System based on Erbium Glass Fiber laser technology operating at a wavelength of 1565 nm. The module delivers laser energy to the treatment area via a handpiece incorporating a galvanometric scanner for delivery of fractional treatment patterns, enabling treatment shape sizes up to 18 mm using either a SapphireCool tip or Precision tip. The system supports multiple predefined fractional scanning patterns with densities of up to 500 micro‑beams/cm², with an optional BrushFX mode that distributes treatment points randomly within the selected pattern.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12011019MULTI–PLATFORM LASER

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