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510(k) Data Aggregation

    K Number
    K003993
    Device Name
    DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)
    Manufacturer
    DORNIER SURGICAL PRODUCTS, INC.
    Date Cleared
    2001-03-26

    (90 days)

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

    DORNIER SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000072
    Device Name
    DORNIER MEDILAS D SKINPULSE
    Manufacturer
    DORNIER SURGICAL PRODUCTS, INC.
    Date Cleared
    2000-06-12

    (154 days)

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

    DORNIER SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001243
    Device Name
    DORNIER MEDILAS H
    Manufacturer
    DORNIER SURGICAL PRODUCTS, INC.
    Date Cleared
    2000-05-24

    (36 days)

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

    DORNIER SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993146
    Device Name
    DORNIER SCANNER HANDPIECE
    Manufacturer
    DORNIER SURGICAL PRODUCTS, INC.
    Date Cleared
    1999-11-08

    (49 days)

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

    DORNIER SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dornier Scanner handpiece is intended to be used in general and surgical procedures for incision / excision, vaporization, ablation, and coagulation of soft tissue and cartilage. The Dornier Scanner may also be used for skin resurfacing. The Dornier Scanner is for use as an accessory for the Dornier Medilas E Laser (K981438). It is indicated for use in medicine and surgery in the medical specialties as listed in the Indication for Use Statement for the Dornier Medilas E Laser System. No new indications are being requested.
    Device Description
    The Dornier Scanner handpiece is intended to be used in general and surgical procedures for incision / excision, vaporization, ablation, and coagulation of soft tissue and cartilage. The Dornier Scanner may also be used for skin resurfacing. The Dornier Scanner is for use as an accessory for the Dornier Medilas E Laser (K981438).
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    K Number
    K991183
    Device Name
    DORNIER LASERTRODE FIBER
    Manufacturer
    DORNIER SURGICAL PRODUCTS, INC.
    Date Cleared
    1999-06-09

    (62 days)

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

    DORNIER SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Domier Lasertrode fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes, or for open surgery for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue. The Dornier Lasetrode is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT and General Surgery.
    Device Description
    Not Found
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    K Number
    K984591
    Device Name
    DORNIER MEDILAS H/2
    Manufacturer
    DORNIER SURGICAL PRODUCTS, INC.
    Date Cleared
    1999-03-26

    (88 days)

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

    DORNIER SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dornier Medilas H/2 Laser is intended to be used in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparascopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece). The Dornier Medilas H/2 Laser is indicated for use in medicine and surgery in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.
    Device Description
    Not Found
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    K Number
    K982629
    Device Name
    DORNIER MEDILAS D
    Manufacturer
    DORNIER SURGICAL PRODUCTS, INC.
    Date Cleared
    1998-09-14

    (48 days)

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

    DORNIER SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dornier Medilas D Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece). The Dornier Medilas D is indicated for use in medicine and surgery, in the following medical specialties: - Urology - Plastic Surgery - General Surgery - Dermatology - Gynecology - Pulmonary Surgery - Gastroenterology - ENT - Radiology
    Device Description
    The Dornier Medilas D laser is a 50 W diode laser that emits laser radiation in the invisible range of 940 nm. It offers laser power of 0-50 W at the distal tip of the light guide, adjustable in 1 W steps, and offers adjustable pulse duration. It has software controlled operating modes including Standard, Fibertom, LITT and LPS. It uses a 0.1mW Diode laser aiming beam with a wavelength of 645 nm. It incorporates a graphic display showing laser operating parameters, application modes, time functions, system status and messages for the user. It has a cooling system which includes an air-cooled, temperature controlled internal closed circuit water system. It is based on a single shutter with two parallel running microprocessors.
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    K Number
    K981438
    Device Name
    DORNIER MEDILAS E
    Manufacturer
    DORNIER SURGICAL PRODUCTS, INC.
    Date Cleared
    1998-07-20

    (90 days)

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

    DORNIER SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dornier Medilas E Laser 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 Dornier Medilas E may also be used for skin resurfacing. The Dornier Medilas E is indicated for use in medicine and surgery, in the following medical specialties: - Dermatology - Plastic Surgery - General Surgery - Urology - Gynecology - Pulmonary Surgery - Gastroenterology - ENT - Thoracic Surgery - Oral & Maxillofacial Surgery - Ophthalmology - Podiatry
    Device Description
    Not Found
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    K Number
    K981718
    Device Name
    DORNIER MEDILAS H
    Manufacturer
    DORNIER SURGICAL PRODUCTS, INC.
    Date Cleared
    1998-07-17

    (63 days)

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

    DORNIER SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dornier Medilas H Laser is intended to be used in cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery. The Dornier Medilas H Laser is indicated for use in medicine and surgery, in the following specialities: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.
    Device Description
    The Dornier Medilas H Pulsed Holmium YAG Laser is a compact pulsed HO:Yag laser emitting laser radiation in the invisible range of 2080 nm. The Medilas H provides a temperature controlled method for contact cutting and non contact coagulation and vaporization with a bare fiber.
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