BEUDAMED
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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

    TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·June 13, 2018

    ZIL FOR SRL

    Manufacturer
    🇮🇹 Italy

    ALTHEA PLUS

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    ALT19R

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    ARIEL

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    ALTHEA.F

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    CHILDREN 3KA

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    ALTHEA 19 PLUS

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    ALT19M

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    ALT19

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    ALTHEA.M

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    ARIEL PLUS

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    ALTHEA

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    ALTHEA.R

    Device
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·On the market·32 countries

    ALTHEA

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·OFF CARR Srl·12 devices

    Kabo S.r.l.

    Authorized representative
    🇮🇹 Italy·1 Manufacturer

    Youmed S.r.l.

    Manufacturer
    🇮🇹 Italy

    FASTMEDITALIA S.R.L.

    Manufacturer
    🇮🇹 Italy

    IDENT H.C. S.R.L.

    Manufacturer
    🇮🇹 Italy