PREMIO 32 EVO laser A-G program

Organization name

Sedatelec

SRN

FR-MF-000020946

Manufacturer status

Active

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

• CW010

  • Direct contact with mucosal membranes (only for PREMIO 30 EVO and 32 EVO) or broken skin. • Treatment of endocrine areas (particularly in children). • Treatment of the globe of the eye. • Treatment of abdomen in pregnant women. • Treatment of the chest region in a patient with a cardiac pacemaker. • Previous use of anticoagulants and aspirin. • Past history of cheloid or hypertrophic scarring. • Active infection/compromised immune system. • Past history of herpes And more specifically, for people with a history of photo sensitivity: • Exposure to sunlight or artificial UV light for 3 to 4 weeks before treatment. • Hypersensitivity to light at 905 nm. • Receipt of medicines when exposure to sunlight is contraindicated • Receipt of oral isotretinoin medicines or anticoagulants

Primary placement in France; available across 16 countries total.

Trade name

PREMIO 32 EVO laser A-G program

UDI-DI code

03760262493138

Basic UDI-DI

B-03760262493138

Reference / catalog number

112049

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z120615THERAPEUTIC LASERS

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