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510(k) Data Aggregation

    K Number
    K142286
    Device Name
    NS3000 Holmium Laser System
    Manufacturer
    New Star Lasers, Inc.
    Date Cleared
    2014-10-31

    (74 days)

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

    New Star Lasers, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NS3000 laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery. Urology: Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: urethral strictures, bladder neck incisions (BNI), ablation and resection of bladder tumors, uretheral tumors and ureteral tumors, condylomas, and lesions of external genitalia. Lithotripsy and Percutaneous Urinary Lithotripsy: Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi, endoscopic fragmentation of kidney calculi, and treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed. General Surgery: Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: skin incision, excision of external and internal lesions, complete or partial resection of internal organs, tumors and lesions, and biopsy.
    Device Description
    The New Star Model NS3000 is a compact, portable, self-contained system that produces a beam of infrared radiation at 2,100 nm wavelength for treatment, and a visible laser diode beam at 532 nm for aiming. The system emits a pulsed laser beam which is delivered to the treatment site using a fiber-optic delivery system. The system consists of a laser console, a fiber-optic delivery system, and a footswitch. The system provides safety features that are designed to protect the user and patient from high voltages and laser emissions. The console consists of a control panel, a laser head assembly, a power supply, and a cooling system. It also contains an ON/OFF key switch, Emergency Off switch, External Power Meter connector, Fiber-Optic receptacle, Interlock Jumper plug/receptacle, and a footswitch receptacle. The fiber-optic delivery system includes a linear flash lamp pumped holmium laser cavity and resonator, a 3 milliwatt laser diode, two optical detector assemblies, lenses and cables. The footswitch is used to initiate delivery of laser energy according to preset parameters.
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    K Number
    K132607
    Device Name
    NS 2500 HOLMIUM LASER SYSTEM
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2014-03-21

    (213 days)

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

    NEW STAR LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NS2500 laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery Urology: Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: urethral strictures, bladder neck incisions (BNI), ablation and resection of bladder turnors, uretheral tumors and ureteral tumors, condylomas, and lesions of external genitalia Lithotripsy and Percutaneous Urinary Lithotripsy: Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi, endoscopic fragmentation of kidney calculi, and treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Open, laparoscopic and endoscopic surgery (incision, excision, General Surgery: resection, ablation, vaporization, coagulation and hemostasis) including: skin incision, excision of external and internal lesions, complete or partial resection of internal organs, tumors and lesions. and biopsy
    Device Description
    The New Star Model 2500 is a compact, portable, self-contained system that produces a bearn of infrared radiation at 2,100 nm wavelength for treatment, and a visible laser diode beam at 532 nm for aiming. The system emits a pulsed laser beam which is delivered to the treatment site using a fiber-optic delivery system. The system consists of a laser console, a fiber-optic delivery system, and a footswitch. The system provides safety features that are designed to protect the user and patient from high voltages and laser emissions. The console consists of a control panel, a laser head assembly, a power supply, and a cooling system. It also contains an ON/OFF key switch, Emergency Off switch, External Power Meter connector, Fiber-Optic receptacle, Interlock Jumper plug/receptacle, and a footswitch receptacle. The fiber-optic delivery system includes a linear flash lamp pumped holmium laser cavity and resonator, a 3 milliwatt laser diode, two optical detector assemblies, lenses and cables. The footswitch is used to initiate delivery of laser energy according to preset parameters.
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    K Number
    K103338
    Device Name
    COOLTOUCH
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2011-11-01

    (351 days)

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

    NEW STAR LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For CoolTouch VariaBreeze™ with CoolBreeze® Handpiece: Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. For CoolTouch VariaBreeze™ with Toenail Handpiece: Indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
    Device Description
    The CoolTouch VariaBreeze Laser System is an Nd: YAG laser using a flashlamp-pumped solid state laser rod to produce laser emission at 1064 nm. The laser consists of a cabinet that houses the following: Control panel with microcontroller and emergency stop button, standby button, ready button, and key switch; Connector port for fiber optic delivery system; Remote interlock connector; 630 to 680 nm diode aiming beam; Power supply; Cooling system; Connector port for footswitch and power cord. Delivery devices for the VariaBreeze include: CoolBreeze Handpiece for CoolBreeze Mode—Contains non-replaceable fiber optic within a flexible cable connected to the laser. A standoff at the tip allows for non-contact use, and a control dial is used to set the spot size from 2mm to 10mm. The handpiece also has cryogen for topical cooling. The handpiece is cleanable and reusable. Toenail Handpiece for Toenail Mode—The fiber optic cable attaches to the laser. The handpiece features a standoff at the tip to provide the correct placement for laser delivery to the treatment site and is reusable and cleanable.
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    K Number
    K101783
    Device Name
    COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2010-09-13

    (80 days)

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

    NEW STAR LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoolTouch Model CT3PZ Nd:YAG Surgical Laser is indicated for the following: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for treatment of fine lines and wrinkles; for treatment of mild to moderate inflammatory acne vulgaris; for treatment of back acne and atrophic acne scars, and; for podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: o matrixectomy o periungal and subungal warts o plantar warts o radical nail excision o neuromas
    Device Description
    The CoolTouch CT3PZ Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with fiber optic handpiece setup.
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    K Number
    K092964
    Device Name
    COOLTOUCH VARIA ND:YAG LASER SYSTEM
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2009-12-11

    (77 days)

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

    NEW STAR LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The soft tissue applications are for the coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissues including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Dermatology: For hair removal (destruction of hair follicles) in all skin types and for coagulation and hemostasis of vascular lesions and soft tissue applications. In addition to the tissue types cited, pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; for patients with lesions that have not responded to other laser treatments. Also for the treatment of fine lines and wrinkles. Endoscopic/Laparoscopic General Surgery: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic, laparoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy. Gastroenterology: Tissue ablation and hemostasis in the Gl tract; esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; GI hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding ulcers, gastric erosions, GI tissue ablation, including benign and malignant neoplasms, angiodysplasia; polyps, ulcer, colitis, and hemorrhoids. General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation. Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intrauterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine spetum. Head and Neck/Otorhinolaryngology (ENT): Coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissue. Hemostasis during surgery: Adjunctive coagulation and hemostasis (control of bleeding) during surgery (endoscopic, laparoscopic, and open procedures). Neurosurgery: Hemostasis of pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma. Oculoplastics: Incision, excision, vaporization, ablation, and coagulation of soft tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation of the eyeball, exteneration of orbital contents. Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthoscopic applications. Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue. Pulmonary/Thoracic Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. Thoracic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue, including lung tissue, in thoracic applications including but not limited to isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets. Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma accuminata). Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neromas.
    Device Description
    The CoolTouch Varia Laser System is an Nd:YAG laser producing laser emission at 1064 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with fiber optic handpiece setup.
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    K Number
    K090410
    Device Name
    COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2009-03-27

    (37 days)

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

    NEW STAR LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a sensing device to measure and display the temperature of the treatment area during procedures with the NS-130 laser.
    Device Description
    The Thermal Sensing Handpiece Accessory is a temperature detector which will provide the laser operator with a readout of the temperature of the treatment area
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    K Number
    K081628
    Device Name
    MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2008-06-20

    (10 days)

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

    NEW STAR LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoolTouch Model LC225/CoolTouch CoolLipo Nd:YAG Surgical Laser is indicated for the following: a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; b) for use in the treatment of fine lines and wrinkles; c) for treatment of back acne and atrophic acne scars; d) for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; e) for laser-assisted lipolysis.
    Device Description
    The LC225/CoolLipo Nd:YAG Laser System produces laser emission at 1320nm. The laser consists of three interconnected sections: the cabinet which houses the power supply, the cooling system, the microcontroller and the laser, the fiber optics, and the handpiece or JouleTracker
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    K Number
    K080163
    Device Name
    COOLTOUCH MODELS LC215 AND COOLLIPO
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2008-04-10

    (78 days)

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

    NEW STAR LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In addition to previously cleared indications for use, the CoolTouch Model LC215/CoolLipo Nd:YAG Surgical Laser is indicated for laser-assisted lipolysis.
    Device Description
    The CoolTouch LC215/CoolLipo Surgical Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with microcannula setup.
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    K Number
    K072751
    Device Name
    COOLTOUCH MODELS NS 160 AND LC215 COOLIPO
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2008-01-02

    (97 days)

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

    NEW STAR LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In addition to previously cleared indications for use, the CoolTouch Model NS160 CoolLipo Nd: Y AG Surgical Laser is indicated for laser-assisted lipolysis.
    Device Description
    CoolTouch CoolLipo The NS160 Nd: YAG Surgical Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with microcannula setup.
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    K Number
    K072424
    Device Name
    COOLTOUCH, MODEL LC215,COOLLIPO
    Manufacturer
    NEW STAR LASERS, INC.
    Date Cleared
    2007-10-03

    (35 days)

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

    NEW STAR LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoolTouch Model LC215 Nd:YAG Surgical Laser is indicated for the following: a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; b) for use in the treatment of fine lines and wrinkles; c) for treatment of back acne and atrophic acne scars, and; d) for treatment of reflux of the great and small saphenous veins associated with varietse veins and varicosities.
    Device Description
    The LC215 Nd: YAG Laser System produces laser emission at 1320nm. The laser consists of three interconnected sections: the cabinet which houses the power supply, the cooling system, the microcontroller and the laser, the fiber optics, and the handpiece or JouleTracker
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