Cynosure Lutronic Technology Corporation

Certificat C771533

Rév. 2Modifié

Valide jusqu'au: 16 mars 2031

Le certificat C771533 est un certificat Système de management de la qualité valide délivré à Cynosure Lutronic Technology Corporation et enregistré dans EUDAMED. Valable jusqu'au 16 mars 2031. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: C771533
Type de certificat: Système de management de la qualité
Statut du certificat: Modifié
Législation applicable: MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]
Version: 2
Identifiant du certificat: 2460C7715332

Validité

Délivré le: 15 juil. 2026
Valide à partir du: 15 juil. 2026
Valide jusqu'au: 16 mars 2031

Fabricant

Fabricant: Cynosure Lutronic Technology Corporation
SRN du fabricant: KR-MF-000047499
Pays du fabricant: Corée du Sud

Organisme notifié

Organisme notifié
SRN de l'organisme notifié: 2460
Pays de l'organisme notifié: Norvège

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

: Oui
: Non
: Non
: Non
: Non
: Non
: Non
: Oui
: Non
: Non
: Non

Historique

Changements de statut

Modifié

Remplace

C771533Système de management de la qualitéDélivré16 mars 2026 → 16 mars 2031

Périmètre de couverture

Classe IIb20Classe IIa2

22 périmètres

Electrosurgical Unit (Intended purpose: It is indicated to be used by a trained physician for improving acne scars on the face.)
Classe IIb
Long pulsed Nd:YAG Laser (Intended purpose: It is intended for use in the medical specialty of dermatology requiring selective photothermolysis of target chromophores in soft tissue. The 532 nm wavelength is intended to be used by a trained physician as treatment of the following: - Benign vascular lesions, including Spider veins of the lower extremities - Benign cutaneous lesions, including Erythematous scars The 1064 nm wavelength is intended to be used by a trained physician as treatment
Classe IIb
Long-pulsed Alexandrite + Nd:YAG Laser Long-pulsed Alexandrite Laser (Intended purpose: It is intended for use in the professional healthcare facility environment requiring selective photothermolysis of target chromophores in desired tissue. The 755 nm wavelength is intended to be used by a trained physician for: - Reduction of pseudofolliculitis barbae (PFB) - Lightening of hypertrophic, dark and/or resistant Port wine stains (PWSs) - Removal of congenital melanocytic nevi (CMN)
Classe IIb
Frequency Doubled Q-switched Nd-YAG Laser system (Intended purpose: Epidermal Pigmented Lesions, Epidermal & Dermal Pigmented Lesions, Dermal Pigmented Lesions. - Café-au-lait macules - Nevus of Ota - ABNOM (Hori’s Nevus))
Classe IIb
Thulium laser (Intended purpose: It is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.)
Classe IIb
Electrosurgical Unit (No intended medical purpose) (Intend purpose: The XERF device is intended as a non-invasive dermatological aesthetic treatment device. - Facial lines and wrinkles - Lift the eyebrow - Facial and neck laxity)
Classe IIb
Electrosurgical Electrode (No intended medical purpose) (Intended purpose: The XERF device is intended as a non-invasive dermatological aesthetic treatment device. - Facial lines and wrinkles - Lift the eyebrow - Facial and neck laxity)
Classe IIb
Surgical CO2 Laser (RF Type) (Intended purpose: The eCO2 3D is applicable for indication using by a trained physician for procedures requiring the ablation, vaporization, excision, incision and coagulation of soft tissue. This system can be applied for any of the following indications: - Scars that are associated with a medical condition, such as hypertrophic scar burn scars and surgical scar - Wart)
Classe IIb
Surgical CO2 Laser (RF Type) (Intended purpose: The eCO2 DENTA is applicable for indication using by a trained physician for procedures requiring the ablation, vaporization, excision, incision and coagulation of soft tissue. This system can be applied for any of the following indications: - Oral Leukoplakia - Fibrous hyperplasia)
Classe IIb
Er:Glass Laser (Intended purpose: It is intended used for following indication: - Scar)
Classe IIb
Phototherapy Unit
Classe IIa
LUTRONIC GENIUS (Treatment time: Option 1:10~1000ms, Option 2:10~600ms) Disposable accessories: - GENIUS Tip (G49D, M81D, M49D, P16D, P14D)
Classe IIb
DermaV
Classe IIb
CLARITY II (ICD Type), CLARITY II (AIR Type), CLARITY II LPA (ICD Type), CLARITY II LPA (AIR Type)
Classe IIb
HOLLYWOOD SPECTRA
Classe IIb
LaseMD Ultra
Classe IIb
XERF
Classe IIb
XERF EFFECTOR 40(300, 600 900), 60(600, 900, 1200))
Classe IIb
eCO2 3D
Classe IIb
eCO2 DENTA
Classe IIb

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