Lutronic Corporation

Certificat C555614

Rév. 0Annulé

Valide jusqu'au: 4 juil. 2029

Le certificat C555614, un certificat Système de management de la qualité délivré à Lutronic Corporation, a été retiré. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: C555614
Type de certificat: Système de management de la qualité
Statut du certificat: Annulé
Législation applicable: MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]
Version: 2
Identifiant du certificat: 2460C5556140

Validité

Délivré le: 4 juil. 2024
Valide à partir du: 4 juil. 2024
Valide jusqu'au: 4 juil. 2029

Fabricant

Fabricant: Lutronic Corporation
SRN du fabricant: KR-MF-000009035
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
: Non

Historique

Changements de statut

Annulé

Remplace

C555614Système de management de la qualitéDélivré4 juil. 2024 → 4 juil. 2029

Périmètre de couverture

Classe IIb10Classe IIa2

12 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 avelength 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 avelength is intended to be used by a trained physician for: - reducing the papule of Pseudofolliculitis barbae (PFB) - improving the Port-wine stain - removing the Congenital Melanocytic Nevi (CMN) The 1064 nm wavelength is intended to be used by
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
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), IIb CLARITY II LPA (AIR Type)
Classe IIb
HOLLYWOOD SPECTRA
Classe IIb
LaseMD Ultra
Classe IIb
HEALITE II Accessories: - 830nm/590nm Head - 830nm/590nm + 633nm Head - 830nm/590nm + 415nm Head
Classe IIa

Documents

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