21 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Italy
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LASER PER FISIOTERAPIA LASERIX PH12
Device
EU MDD
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Eu Md Class 2b
·GN MED s.r.l.·On the market·1 country
LASER PER FISIOTERAPIA LASERIX PH3
Device
EU MDD
·
Eu Md Class 2b
·GN MED s.r.l.·On the market·1 country
LASER PER FISIOTERAPIA LASERIX PHP
Device
EU MDD
·
Eu Md Class 2b
·GN MED s.r.l.·On the market·1 country
DOLORCLAST HIGH POWER LASER
Device
EU MDR
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Eu Md Class 2b
·GN MED s.r.l.·On the market·32 countries
LASERIX PRO SMART
Device
EU MDR
·
Eu Md Class 2b
·GN MED s.r.l.·On the market·3 countries
LASERIX PRO
Device
EU MDR
·
Eu Md Class 2b
·GN MED s.r.l.·On the market·3 countries
Laserix PRO
Device
EU MDD
·
Eu Md Class 2b
·GN MED s.r.l.·On the market·3 countries
Laserix PH10
Device
EU MDD
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Eu Md Class 2b
·GN MED s.r.l.·On the market·1 country
ARM DolorClast Laser
Device
EU MDR
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Eu Md Class 1
·GN MED s.r.l.·On the market·32 countries
Farmaka Acne Cream (FAC)
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Farmaka srl·1 device
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI, including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles, fine lines and wrinkles, treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions.
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·January 23, 2013
Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·January 23, 2013
LASER PER FISIOTERAPIA LASERIX PH3
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·GN MED s.r.l.·1 device
Laserix PhP
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·GN MED s.r.l.·1 device
LASER PER FISIOTERAPIA LASERIX PH12
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·GN MED s.r.l.·1 device
LASERIX PRO
Basic UDI-DI
EU MDR
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Eu Md Class 2b
·GN MED s.r.l.·3 devices
Laserix PH10
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·GN MED s.r.l.·1 device
Laserix PRO
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·GN MED s.r.l.·1 device
BRACCIO DOLORCLAST LASER
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·GN MED s.r.l.·1 device
MED27021
Certificate
MDD Annex II (excluding section 4)·GN MED s.r.l.·KIWA CERMET ITALIA S.P.A.·2 Basic UDI-DIs