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Organization name
UDI-DI code
Reference / catalog number

UGAC-2010960GR — Class IIb MDR by Lumenis (Germany) GmbH

MD Atlas
Lumenis (Germany) GmbH

EUDAMED last updated this device on Apr 23, 2026

UGAC-2010960GR

426053918YAGHPC5

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lumenis (Germany) GmbH
UDI-DI code: 04260539181151
Reference / catalog number: UGAC-2010960GR

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Manufacturer information

Organization name: Lumenis (Germany) GmbH
SRN: DE-MF-000007655
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW013
EUDAMED did not publish a description for this code.
CW016
EUDAMED did not publish a description for this code.
CW275
EUDAMED did not publish a description for this code.
CW010
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.
CW169
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260539181151
Basic UDI-DI: 426053918YAGHPC5
Reference / catalog number: UGAC-2010960GR
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Stellar M22™ Q‑Switched Nd:YAG Upgrade Kit includes a solid‑state Nd:YAG laser module and accessories operating at a wavelength of 1064 nm. The Q‑Switched Nd:YAG handpiece generates short, high‑intensity laser pulses in the nanosecond range for thermomechanical tissue interaction and incorporates safety switch mechanisms, treatment tips and lens assemblies in multiple spot sizes.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011019MULTI–PLATFORM LASER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification