GA-0005500DIGGR

Organization name

Lumenis (Germany) GmbH

SRN

DE-MF-000007655

Manufacturer status

Active

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

• CW007

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

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

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

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

  EUDAMED did not publish a description for this code.
• CW010

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

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

  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

04260539181922

Basic UDI-DI

426053918OPTJF

Reference / catalog number

GA-0005500DIGGR

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 Digital OptiLight is a multi‑technology platform based on Intense Pulsed Light (IPL) technology operating within a wavelength spectrum of 400–1200 nm. The system enables selective photothermolysis through delivery of light energy in triple sub‑pulse sequences, with preset pulse duration and inter‑pulse interval values to target melanin and hemoglobin chromophores. In its default configuration, the Digital OptiLight includes an IPL handpiece operated with a 590 nm cut‑off ExpertFilter and an OPT module consisting of a fiber bundle connected to a pen‑like handpiece designed for treatment of smaller areas using a disposable plastic Opti‑Tip. The system console incorporates a touchscreen control panel, power supply modules, cooling unit, switching module and integrated control software for monitoring and selection of treatment parameters. The Digital OptiLight includes LumenisX connectivity capability through an internal cellular modem and Wi‑Fi connection for service purposes, enabling remote equipment registration, system activation and transmission of anonymized performance and usage data without collection or storage of personal patient data. System operation is controlled via proprietary GUI application software and device controller firmware hosted on the main controller board. The platform may be upgraded to support additional treatment modules including Multi‑Spot Nd:YAG, Q‑Switched Nd:YAG and ResurFX laser modules.

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