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510(k) Data Aggregation

    K Number
    K160470
    Device Name
    SculpSure
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2016-07-21

    (153 days)

    Product Code
    PKT, OOK
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYNOSURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cynosure SculpSure is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen and flanks.
    Device Description
    The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.
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    K Number
    K150587
    Device Name
    Cortex Laser System
    Manufacturer
    Cynosure, Inc. dba Ellman
    Date Cleared
    2015-07-21

    (134 days)

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

    Cynosure, Inc. dba Ellman

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CO2 laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology, neurosurgery, orthopedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing. The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery, general surgery. Dermatology, Plastic Surgery and General Surgery procedures: - · Laser skin resurfacing. - · Treatment of furrows and wrinkles. · Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation. - · Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. - · Blepharoplasty. - · Site preparation for hair transplants. - · The fractional scanner is for skin resurfacing. The Er: YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
    Device Description
    The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. The Er: Y AG handpiece attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.
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    K Number
    K150724
    Device Name
    SculpSure
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2015-07-01

    (103 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYNOSURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cynosure SculpSure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
    Device Description
    The Cynosure SculpSure is a diode laser system. Electrically efficient semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. The main components of SculpSure are a console and applicator.
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    K Number
    K150230
    Device Name
    SculpSure
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2015-05-15

    (102 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYNOSURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cynosure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
    Device Description
    The Cynosure SculpSure is a diode laser system. Electrically efficient semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. The main components of SculpSure are a console and applicator.
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    K Number
    K143105
    Device Name
    Picosure Workstation
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2015-02-23

    (117 days)

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

    CYNOSURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    755 nm: The PicoSure workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV. 532 nm: The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I-III.
    Device Description
    The PicoSure™ workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755 nm handpiece, an optional 532 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. This 532 nm Laser Delivery System converts the 755 nm laser energy into a 532 nm wavelength and is available in multiple spot sizes.
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    K Number
    K141511
    Device Name
    SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2015-01-23

    (228 days)

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

    CYNOSURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440mm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers for surgical incision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs and gland) laser assisted lipolysis and the treatment of primary axillary hyperhidrosis.
    Device Description
    The Cynosure 1440nm Wavelength laser is solid state Nd: YAG laser, having a neodymium rod as a lasing medium. Laser activation is by footswitch. Overall weight of the laser is 220lbs, and the size is 38.6"x16.5"x35.5" (HxWxD). Electrical requirement is 230 VAC, 16A, 50-60 Hz, single phase. SideLaze800™ Laser Beam Delivery Accessory is an optional side-firing fiber optic accessory used with the Cynosure Lasers with 1440nm wavelength. The SideLaze800™ option is intended to offer physicians a convenient accessory.
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    K Number
    K142376
    Device Name
    Palomar Icon Aesthetic System
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2014-09-24

    (29 days)

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

    CYNOSURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions. The 2940 Fractional Ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia. The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars. The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The 1540 Fractional Non-ablative Laser and 2940 Fractional Abaltive Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrides, furrows, fine lines, textural irregularities, dyschromia and pigmend lesions. The 1440 Fractional Non-ablative Laser Handpiece and 2940 Fractional Ablative Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularties, dyschromia and pigmented lesions. The MaxIR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of may also help muscle spasms, minor sprains and strains, and minor muscular back pain. The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); 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/light treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (FFB). The Max series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae, removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including port wine stains, hemangiomas, aniomas, telangiectasias, rosacea, facial and leg veins. The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.
    Device Description
    The Palomar Icon® Aesthetic System including attachable treatment handpieces is designed to deliver pulses of broadband incoherent or laser light to a predetermined target site. The Palomar Icon® Aesthetic System consists of three stacking modules that contain an internal power supply, control electronics, Chiller Module, Heat Exchanger Module, Base Module, remote interlock, emergency-off button, footswitch, power control, and front panel monitor with indicators. They system includes multiple treatment hadnpieces attached to the Base Module. Each Handpiece provides laser energy at a specific wavelength or Intense Pulsed Light (IPL) at a specific range.
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    K Number
    K140719
    Device Name
    PICOSURE WORKSTATION
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2014-09-22

    (185 days)

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

    CYNOSURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure™ workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.
    Device Description
    The PicoSure™ workstation is a high powered Alexandrite system that delivers laser energy in the 755-nm wavelength. The system consists of a console that houses the power supply, control electronics and the laser. Laser energy is delivered to the skin via an articulated arm. The laser is activated using a footswitch.
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    K Number
    K141425
    Device Name
    ELITE + LASER SYSTEM
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2014-09-11

    (104 days)

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

    CYNOSURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    755 nm: The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowting when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064 nm: The Cynosure Elite+ Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Cynosure Elite+ laser has an Alexandrite crystal rod as the lasing medium, with a wavelength of 755 nm. The 1064 nm wavelength is generated from the Nd:YAG laser head. Laser activation is by either by finger or foot switch. The overall weight of the laser is 180 lbs and the size is 41 x 15 x 25 in (HxWxD). Electrical equipment is 208/240 VAC, single phase, 30A, 50/60 Hz. The modifications to this device are four handpieces allowing for a larger treatment area; 18 mm, 20 mm, 22 mm and 24 mm. The 1064 Nd:YAG laser did not require any modifications to support the new handpieces. Minor modifications, including rod diameter change and lamp fill pressure change, were made to the Alexandrite laser to increase the energy to support the larger spot sizes. The software continues to control the energy based on the handpiece attached. This prevents the increase in available energy from the laser from increasing the fluence of the existing spot sizes.
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    K Number
    K133364
    Device Name
    PICOSURE WORKSTATION
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2014-07-22

    (263 days)

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

    CYNOSURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PicoSure™ workstation is indicated for tattoo and benign pigmented lesion removal. The PicoSure™ workstation operating with the 3mm or 6mm handpiee and the FOCUS lens array is indicated for the treatment of acne scars in Fitzpatrick skin types I-IV.
    Device Description
    The PicoSure™ workstation is a high-powered, Q-switched Alexandrite system that delivers laser energy in the 755-nm wavelength. The system consists of a console that houses the power supply, control electronics and the laser. Laser energy is delivered to the skin via an articulated arm. The laser is activated using a footswitch.
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