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510(k) Data Aggregation

    K Number
    K951033
    Device Name
    ANDELA DYNAMIC COOLING DEVICE
    Manufacturer
    CANDELA LASER CORP.
    Date Cleared
    1996-08-15

    (528 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANDELA LASER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Candela Dynamic Cooling Device is to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to reduce pain associated with laser treatment.
    Device Description
    Candela's Dynamic Cooling Device consists of 1) a source of skin refrigerant fluid (CFC R-12), 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with an SPTL laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of CFC R-12 just prior to the delivery of a laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. Thermal injury to non-vascular structures is minimized and pain associated with the laser treatment is reduced.
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    K Number
    K955662
    Device Name
    CANDELA Q-SWITCHED ALEXANDRITE LASERS
    Manufacturer
    CANDELA LASER CORP.
    Date Cleared
    1996-06-14

    (185 days)

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

    CANDELA LASER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    intended for use in the treatment of pigmented lesions and tattoos.
    Device Description
    The Candela Q-Switched Alexandrite Lasers utilize an alexandrite rod (crystal) which emits pulsed energy at 755 nm in the near-infrared region of the electromagnetic spectrum. An electro-optical Q-Switch is employed to control pulse duration. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Q-Switched Alexandrite Lasers are designed with five major components: - the high voltage power supply and modulator system; 1) - 2) the optical laser head; - 3) the circulator system; - 4) the microprocessor-based system controller and user display panel; - 5) the optical delivery system. The Candela Q-Switched Alexandrite Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an on-board control panel to regulate operation during treatment.
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    K Number
    K955011
    Device Name
    CANDELA HCS 2000 URETHERAL WARMER CATHETER
    Manufacturer
    CANDELA LASER CORP.
    Date Cleared
    1996-04-03

    (154 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANDELA LASER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Candela HCS 2000 Urethral Warmer Catheter System is designed to transfer heat into the urethral membrane during cryosurgical ablation of prostatic tissue using the Cryotech LCS 3000 Cryosurgical System.
    Device Description
    The principal components of the Candela Urethral Warmer are: (1) a saline bottle filled with a saline solution; (2) infrared lamps; (3) a temperature controller; (4) a roller pump; (5) delivery tubing and a balloon catheter with a radiopaque marker at its center; (6) pump tubing (7) return tubing; (8) a urethral/bladder sound (K950633); and (9) a console. The console houses the saline reservoir, the infrared lamps, and the roller pump and digital temperature readouts and buttons for operating the device appear on the front of the console.
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    K Number
    K954872
    Device Name
    CANDELA CRYO-PROBE HOLDER
    Manufacturer
    CANDELA LASER CORP.
    Date Cleared
    1996-02-05

    (104 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANDELA LASER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954934
    Device Name
    CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE
    Manufacturer
    CANDELA LASER CORP.
    Date Cleared
    1996-02-02

    (98 days)

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

    CANDELA LASER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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