Sofwave

Dénomination commerciale

Sofwave

07290018152003

B-07290018152003

Numéro de référence/catalogue

FG00001INT

GS1

Classe IIa

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Sofwave is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles for subjects aged 22 and older. The intended clinical performance of Sofwave is improvement of facial lines and wrinkles.

URL des informations complémentaires

https://sofwave.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Z120610ULTRASOUND THERAPY EQUIPMENT

5 avertissements enregistrés — faire défiler le panneau pour tout voir.

• Demandez conseil à votre pharmacien ou à votre médecin avant d’utiliser ou de prendre le produit (par exemple, en cas de grossesse ou d’allaitement)

  Pregnancy or planning to become pregnant, having given birth less than three months ago, and/or breast feeding.

• Avertissement

  Contraindications:• Open wounds or lesions on the face and/or neck. • Severe or cystic acne on the face and/or neck • Pacemakers and electronic device implants in the treated area.

• Partie appliquée de type BF

  Degree of Protection Against Electric Shock

• Consulter la notice d’utilisation
• Consulter un professionnel de la santé avant toute utilisation

  Precautions:• Presence of any active systemic or local infections. • Presence of active local skin disease that may alter wound healing. • History of chronic drug or alcohol abuse. • Significant scarring in the area to be treated. • Presence of a metal stent or implant in the facial area. • The Sofwave device has not been evaluated for use over various materials. • Treatment is not recommended for use directly over areas with a dermal filler. • Taking Isotretinoin or other retinoid within the past six months. • Taking psychiatric drugs, antiplatelet or anticoagulant within the past six months. • As per the physician's discretion, any physical or mental condition which might make it unsafe for the patient to be treated.