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510(k) Data Aggregation

    K Number
    K053604
    Device Name
    WAVELIGHT IDAS
    Manufacturer
    WAVELIGHT LASER TECHNOLOGIE AG
    Date Cleared
    2006-02-22

    (57 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAVELIGHT LASER TECHNOLOGIE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IDAS laser system is intended for use for Aesthetics: vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. café-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.
    Device Description
    The IDAS laser system (532 nm) is used for the treatment of superficial vascular lesions and for pigmented lesions. The laser radiation emitted by this type of faser system has a wavelength of 532 nm. Radiation of this wavelength is characterized by a particularly strong absorption by hemoglobin and melanin. The radiation emitted by the laser penetrates into the human skin 0.1 - 1 mm thus being able to locally heat up even deeper-lying target structures which consequently leads to the desired effect. The laser system (532 nm) can be used in two different operating modes: In the "cw" (= continuous wave) mode or in the "pulsed" operating mode. Beam transmission is ensured by a fiber and a handpiece with different adapters which are used to adjust the spot diameter on the skin. Beam transmission, however, can be also effected via a bare fiber. While the parameter wavelength is specified by the device, spot size, fluence or power, pulse duration, frequency and the intensity of the aiming beam can be selected by the treating physician for optimal adjustment to individual requirements.
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    K Number
    K052806
    Device Name
    BURANE
    Manufacturer
    WAVELIGHT LASER TECHNOLOGIE AG
    Date Cleared
    2005-10-17

    (13 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAVELIGHT LASER TECHNOLOGIE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BURANE is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The BURANE is indicated for use in skin resurfacing. The BURANE is indicated for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophtalmology & Podiatry. Aesthetic Surgery Skin resurfacing and treatment of wrinkles. Dermatology/Plastic Surgery Indications include, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers. Gastroenterology General Surgery The Er:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation. Genitourinary Indications include lesions of the external genitalia, urethra and anus, penis, condyloma acuminata, giant perineal condyloma (Includes condyloma actinoma), vulvar lesions, polyps and familial polyps of the colon. Gynecology Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. ENT Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia. Oral/Maxillofacial Indications include benign oral tumors, oral and glossal lesions and gingivectomy. Ophtalmology Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy. Podiatry Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
    Device Description
    BURANE is a Er:YAG laser system for dermatological interventions and for aesthetic laser applications. The BURANE has an Ablation Mode and a Coagulation Mode. Furthermore, the laser system enables a quick, precise ablation with minimal thermal damage. Thus an optimal wound healing process is achieved and thermal tissue admission is minimized. This is due to the BURANE's wavelength of 2.94 µm, which has an absorption maximum in water and is absorbed very well by tissue water. The thermal damage zone is thus minimized. While the parameter wavelength is specified by the device, spot size, laser energy, pulse sequence, and coagulation function can be selected by the treating physician for optimal adjustment to individual requirements.
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    K Number
    K051399
    Device Name
    WAVELIGHT AURIGA
    Manufacturer
    WAVELIGHT LASER TECHNOLOGIE AG
    Date Cleared
    2005-06-30

    (30 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAVELIGHT LASER TECHNOLOGIE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AURIGA Holmium Laser system is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.
    Device Description
    The AURIGA is a pulsed solid-state Holmium YAG-Laser System with a wavelength of approx. 2080 nm. The system is suitable for interdisciplinary use in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures) , ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.
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    K Number
    K050317
    Device Name
    BURANE XL
    Manufacturer
    WAVELIGHT LASER TECHNOLOGIE AG
    Date Cleared
    2005-02-24

    (15 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAVELIGHT LASER TECHNOLOGIE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BURANE XL is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in any surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The BURANE XL is indicated for use in skin resurfacing. The BURANE XL is indicated for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic and Aesthetic Surgery, Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophtalmology & Podiatry. Aesthetic Surgery Skin resurfacing and treatment of wrinkles. Dermatology/Plastic Surgery Indications include, epidermal nevi, telangiectasia, spider veins, actinic keratoses, scar revision, debulking benign tumors, decubitis ulcers. Gastroenterology General Surgery The Er:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during general surgery application where skin and subcutaneous tissue is encountered. Indications include excision of external tumors and lesions, complete or partial tissue dissection, excision of external tumors and lesions, tissue ablation and/or vessel coagulation. Genitourinary Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon. Gynecology Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. ENT Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia. Oral/Maxillofacial Indications include benign oral tumors, oral and glossal lesions and gingivectomy. Ophtalmology Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy. Podiatry Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
    Device Description
    BURANE XL is a Er:YAG laser system for dermatological interventions and for aesthetic laser applications. The triple mode technology makes BURANE for aesthetic ideal applications. The Coagulation Mode for different AL an export dother the Ablation Mode for classical ablation procedures, and the combination of both techniques. Furthermore, the laser system enables a quick, precise ablation with minimal thermal tissue damage. Thus an optimal wound health process is achieved. -- the risk of scar formation is minimized. This is due to the BURANE XL's wavelength of 2.94 pm, which has an absorption in water and is thermal damage zone is thus minimized. While the parameters wavelength and pulse form are specified by the device, spot size, laser energy, pulse sequence, and coagulation function can be selected by the treating physician for optimal adjustment to individual requirements.
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    K Number
    K050218
    Device Name
    WAVELIGHT SINON
    Manufacturer
    WAVELIGHT LASER TECHNOLOGIE AG
    Date Cleared
    2005-02-15

    (15 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAVELIGHT LASER TECHNOLOGIE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions. 2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.
    Device Description
    The SINON is a 694 nm Ruby laser system which can be operated in two different modes. The quality-switch or Q-switch or QS Operating Mode is characterized by extremely short pulse widths (ns = 10 °s) and high peak power (MW = 106 W). The QS Operating Mode in the SINON is used for the removal of tattoos and treatment of pigmented lesions. The second mode is the Free-Running Operating Mode which is used for the removal of hair.
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    K Number
    K042474
    Device Name
    ARION
    Manufacturer
    WAVELIGHT LASER TECHNOLOGIE AG
    Date Cleared
    2004-09-29

    (16 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAVELIGHT LASER TECHNOLOGIE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. The ARION Alexandrite Laser is intended for use in dermatology for hair removal for skin types Fitzpatrick I - IV.
    Device Description
    The ARION is a 755 nm solid-state long-pulsed Alexandrite laser system. The beam is directed to the treatment area by a transmission system which is connected to the laser device. The EPI Zoom Ax transmission system consists of a hand piece attachment with a firmly attached fiber and a hand piece. The hand piece insert can be moved within the hand piece and determine the application and parameter ranges. The hand piece insert in the transmission system hand piece can snap into various positions. The number located closest to the hand piece indicates the spot diameter on the skin in mm (spot sizes: 6/8/10/12/14 mm). The integrated hand piece detection feature automatically shows the selected spot diameter on the laser display. The parameter range is also automatically adjusted for the corresponding range. The MedArt 928 scanner for ARION consists of a scanner with a connected transmission system and a spacer with a 8, 9, 10 and 12 mm spot size. The spacer determines the spot diameter on the skin and therefore the parameter range of the configurable energy densities as well. The spacers are inserted into the scanner as shown below and must be inserted into the scanner up to the limit stop position. The spacers now automatically sets a spot diameter of 8, 9, 10, and 12 mm on the skin; this is also shown automatically on the laser display. The parameter range is also automatically adjusted for the corresponding range. For epidermal cooling can be a cooling device adapted to the handpiece / scanner.
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    K Number
    K040433
    Device Name
    SINON
    Manufacturer
    WAVELIGHT LASER TECHNOLOGIE AG
    Date Cleared
    2004-05-19

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAVELIGHT LASER TECHNOLOGIE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions. 2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.
    Device Description
    The SINON is a 694 nm Ruby laser system which can be operated in two different modes. The quality-switch or Q-switch or QS Operating Mode is characterized by extremely short pulse widths (ns = 103s) and high peak power (MW = 106 W). The QS Operating Mode in the SINON is used for the removal of tattoos and treatment of pigmented lesions. The second mode is the Free-Running Operating Mode which is used for the removal of hair.
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    K Number
    K040384
    Device Name
    MYDON C
    Manufacturer
    WAVELIGHT LASER TECHNOLOGIE AG
    Date Cleared
    2004-05-14

    (87 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAVELIGHT LASER TECHNOLOGIE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins. 2. The MYDON C laser system is also indicated for the treatment of wrinkles. 3. The MYDON C is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB). 4. The MYDON C laser system is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. 5. The intended use of the integral cooling system in the MYDON C laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
    Device Description
    The MYDON C is a 1064 nm solid-state long-pulsed Nd: YAG laser system. The beam is directed to the treatment area by a transmission system which is connected to the laser device and consists of a multifunction hose system and a tightly connected hand unit. In the multifunction hose system both laser radiation carrying quartz fiber as well as the cooling and signal leads are contained. The MYDON C transmission system includes skin cooling integrated into the hand unit and cools the area of skin that the laser covers. When the applicator is placed against the skin, its shape and the integrated hand unit cooling system cool the treatment area before, during and after the application of the laser pulse, all in a single step. The hand unit inserts allow for various treatment types and parameter ranges. MYDON C offers the 1.5 and 3 mm hand unit inserts specifically for the treatment of vascular lesions, the 5 mm hand unit insert for the treatment of both vascular lesions and wrinkles, the 7 mm and 10 mm hand unit inserts for hair removal.
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