simLa® 10 (2001)

Organization name

iMS GmbH

SRN

DE-MF-000017774

Manufacturer status

Active

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

• CW016

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

  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

04262486610005

Basic UDI-DI

426248661200120XXXXUA

Reference / catalog number

simLa® 10 (2001)

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 simLa® 10 is a diode laser and emits laser light with a wavelength of approx. 1470nm and approx. 1940nm. The simLa® 10 is a laser system that emits laser radiation in the range of the absorption maxima of light in the tissue at 1470nm and 1940nm. The main absorber for the laser radiation of the simLa® 10 is the water, which is contained in different types of tissue with a different percentage (soft tissue approx. 70% - 90%, bones approx. 8 - 10%). The high absorption coefficient of water is fundamental to achieve the desired effects such as coagulation of soft tissue or denaturation of collagen. The laser radiation is transmitted from the laser base device to the target tissue via application fibers. During treatment with the simLa® 10, patients may be exposed to pain as a side effect of thermal therapy. The doctor demonstrably informs the patient about this before the treatment and ensures that it is minimized by administering anesthetics or similar.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12011016DIODE SURGICAL LASER

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• Expiration date
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