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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(500) — Class IIa MDD by Laser Light…

MD Atlas
Laser Light Orvostechnikai Innovációs Kft.

EUDAMED last updated this device on Nov 15, 2024

2.7(500)

B-SafeLaser500InfraET

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-SafeLaser500InfraET
Reference / catalog number: 2.7(500)

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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-SafeLaser500InfraET
Basic UDI-DI: B-SafeLaser500InfraET
Reference / catalog number: 2.7(500)
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 infrared light (808 nm) of Safe Laser 500 Infra is absorbed in much deeper layers than that of red light lasers (its biological effect is effective at a depth of up to 8 cm), so it can be used excellently, e.g. in the therapy of musculoskeletal diseases, where it has an analgesic and anti-inflammatory effect and accelerates the healing of muscles, tendons, and joints. In case of a larger dose, it is also suitable for the regeneration of joint cartilage surfaces and cartilage. It helps to heal more effectively after dental treatments and surgeries. Accelerates ossification processes when implanting implants. Relieves acute pain during orthodontic treatment and promotes faster tooth movement (shortens the duration of orthodontic treatment) Technical details Power: 500mW continuous (scattered radiation) Class 1 laser product Wavelength: 808nm (infrared laser) + 4 630nm indicator LEDs 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(1800)B-SafeLaser1800Infra45On the market 2.7(150)B-SafeLaser150ETOn 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.