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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

2.7(150) — Class IIa MDD by Laser Light…

MD Atlas
Laser Light Orvostechnikai Innovációs Kft.

EUDAMED last updated this device on Nov 15, 2024

2.7(150)

B-SafeLaser150ET

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Laser Light Orvostechnikai Innovációs Kft.
UDI-DI code: D-SafeLaser150ET
Reference / catalog number: 2.7(150)

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Manufacturer information

Organization name: Laser Light Orvostechnikai Innovációs Kft.
SRN: HU-MF-000017714
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement	May 31, 2014	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-SafeLaser150ET
Basic UDI-DI: B-SafeLaser150ET
Reference / catalog number: 2.7(150)
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The effect of the SL150 device close to the skin surface is approx. It applies to a depth of 3-4 cm, therefore it has a significant role in the treatment of lesions, inflammations and pains close to the surface. The Safe Laser 150 is a soft-laser device designed for versatile use, with many accessories, thus enabling several types of treatment: When placed on the skin, it can be used as a general laser Can also be used to illuminate the nostril with a nose treatment (accessory). Ears and mouth can be treated effectively with fiber optics (can be ordered separately). Special creams can be effectively applied to the skin with a cosmetic treatment (can be ordered separately). Technical details: Power: 150mW continuous (scattered radiation) Wavelength: 660 nm (red light) Battery operation
Additional information URL: https://safelaser.hu/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120615THERAPEUTIC LASERS

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
Serial number
Software identification

Related devices

2.7(500)B-SafeLaser500InfraETOn the market 2.7(1800)B-SafeLaser1800Infra45On the market

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.