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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
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
FDA 510(k)
FDA Class 2
·Radiology
X-View 3D Pan/X-View 2D Pan
FDA 510(k)
FDA Class 2
·Radiology
MEd 20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·9 Basic UDI-DIs
MED20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·6 Basic UDI-DIs
MED 20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·5129 Basic UDI-DIs
ME 20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·2 Basic UDI-DIs
MED 20024
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·1 Basic UDI-DI
20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·3 Basic UDI-DIs
MD 20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·4 Basic UDI-DIs
A-ABU-330-2
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·1 Basic UDI-DI
MED 2023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·1 Basic UDI-DI
MED20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·1 Basic UDI-DI
MED 2'0023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·1 Basic UDI-DI
QCT016521
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·ISTITUTO SUPERIORE DI SANITA'·5 Basic UDI-DIs
EPG032621
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·ISTITUTO SUPERIORE DI SANITA'·8 Basic UDI-DIs
QCT016521
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·ISTITUTO SUPERIORE DI SANITA'·2 Basic UDI-DIs
QCT016521
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
MED 20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·675 Basic UDI-DIs
MED 20023
Certificate
MDD Annex II (excluding section 4)·SWEDEN & MARTINA S.P.A.·KIWA CERMET ITALIA S.P.A.·1 Basic UDI-DI