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    K Number
    K222958
    Device Name
    mJOULE RF System and Accessories
    Manufacturer
    Sciton, Inc.
    Date Cleared
    2024-04-23

    (574 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sciton, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The mJoule RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The mJOULE RF System consists of console and radio frequency delivery accessories. The control console houses the power supply, cooling system and RF delivery system. The treatment parameters are entered via a touchscreen on the console. The user activates RF emission by means of a footswitch.
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    K Number
    K213761
    Device Name
    Joule diVa System
    Manufacturer
    Sciton, Inc
    Date Cleared
    2022-07-19

    (230 days)

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

    Sciton, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JOULE diVa Laser Device with its accessories is intended for coagulation, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes). The JOULE diVa Laser System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
    Device Description
    The JOULE diVa Laser Device consists of a console and laser deliver accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.
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    K Number
    K213350
    Device Name
    mJOULE System and Accessories
    Manufacturer
    Sciton, Inc
    Date Cleared
    2022-04-15

    (189 days)

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

    Sciton, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The mJoule 1064 laser systems and accessories is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The lasers are indicated for pigmented 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 treatments. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Removal of unwanted hair, for the stable long term. or permanent hair reduction through selective of melanin in hair follicles, and for the treatment for pseudo folliculitis barbae (PFB). The mJoule 1064 laser system and accessories is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The mJoule 1064 laser system and accessories is indicated for the treatment of facial wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). Treatment of Aphthous Ulcers. Excision and Vaporization of Herpes Simplex I and II. Laser assisted uvulopalatoplasty (LAUP). Laser assisted lipolysis. Treatment of mild to moderate inflammatory acne vulgaris. Surgical Applications: Incision/excision and cutting, ablation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastic, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia) and urology.
    Device Description
    The mJOULE 1064nm Laser System consists of a console and laser delivery accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, fiber arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.
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    K Number
    K182173
    Device Name
    Joule System
    Manufacturer
    Sciton, Inc
    Date Cleared
    2019-03-06

    (208 days)

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

    Sciton, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JOULE 1927nm Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
    Device Description
    The JOULE 1927nm Laser System consists of a console and laser deliver accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.
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    K Number
    K180508
    Device Name
    JOULE SYSTEM
    Manufacturer
    Sciton, Inc.
    Date Cleared
    2018-05-18

    (81 days)

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

    Sciton, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Joule 2940 nm ProFractional System with its accessories is intended for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dernatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi: Telangiectasia: Spider veins: Actinic chelitis: Keloids: Verrucae: Skin tags: Keratoses: Scar revision (including acne scars).
    Device Description
    The JOULE ProFractional System consists of a console and laser deliver accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.
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    K Number
    K173285
    Device Name
    JOULE SYSTEM
    Manufacturer
    Sciton, Inc
    Date Cleared
    2018-01-29

    (105 days)

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

    Sciton, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Joule 2940 nm ProFractional System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.
    Device Description
    The JOULE ProFractional System consists of a console and laser deliver accessories. It uses focusing optics to deliver thermal energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.
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    K Number
    K122567
    Device Name
    JOULE 810/940/980 MULTI-PLATFORM SYSTEM
    Manufacturer
    SCITON, INC.
    Date Cleared
    2013-06-19

    (300 days)

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

    SCITON, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JOULE 810/940/980 Multi-Platform System (and delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue. The device is specifically indicated for use as follows: 810nm and 980nm Dermatology/Aesthetics: - Photocoagulation of vascular & dermatological lesions of the face and extremities - Photocoagulation of telangiectasia, veinulectasia of the legs and face - Treatment of reticular veins and branch varicosities - Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas - Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi. - Dermatological surgery: Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment. - Seborrheic keratosis - Mixoid cyst - Papillary varix - Acne treatment - Hair removal of unwanted hair from skin type I-V Plastic Surgery: - Cut, coagulation & vaporization - Resurfacing - Blepharoplasty Vascular Surgery: - Endoluminal or endovenous laser surgery for saphenous incompetent veins 810nm Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The JOULE Multi-Platform System is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. It is also indicated for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins. Permanent hair reduction is defined as the 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. 940nm The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. 980nm The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) is indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue endovenous occlusion of the greater saphenous vein. The JOULE 980 System is further indicated for laser assisted lipolysis. The device is specifically indicated for use as follows: Dermatology, Plastic Surgery and Podiatry: Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, skin, fat or muscle tissue and dermabrasion. Examples include: - Matrixectomy - Excision of neuromas - Excision of periungual and subungual warts - Excision of plantar warts - Excision of keloids - Excision of cutaneous lesions - Dermabrasion - Vaporization and hemostasis of capillary hemangioma - Debridement of wounds - Photocoagulation of teleangectasia of the legs and face - Photocoagulation of vascular lesions of the face and extremities - Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. - Treatment of reticular veins and branch varicosities Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux: Indicated for use with their delivery accessories in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
    Device Description
    The JOULE 810/940/980 Multi-Platform System consist of a console and laser deliver accessories. It uses focusing optics to deliver thermal energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.
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    K Number
    K111483
    Device Name
    JOULE CLEARSENSE LASER SYSTEM
    Manufacturer
    SCITON, INC.
    Date Cleared
    2011-12-07

    (190 days)

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

    SCITON, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JOULE ClearSense Laser System is indicated for ablation, vaporization, incision, excision and coagulation of soft tissue, including: - Matrixectomy - Periungual and subengual warts - Planter warts - Radical nail excision - Neuromas It is also 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 JOULE ClearSense Laser System is a transportable medical device used for the treatment of temporary increase in clear nail in patients with onychomycosis. It uses Nd:YAG laser with a wavelength of 1064 nm. ClearSense uses the laser energy to heat the target to a temperature that is sufficient to destroy it, but not to the point that the heat damages skin and surrounding tissue. The ClearSense system consists of a control console, a foot switch, articulated. arm and a handpiece with a stainless steel guide tip (spacer) attached at its end. Control Console houses the power supply, control electronics, cooling system and optics to direct the laser beam to the input of the articulated arm.
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    K Number
    K101916
    Device Name
    JOULE MULTI-PLATFORM SYSTEM
    Manufacturer
    SCITON, INC.
    Date Cleared
    2011-03-18

    (252 days)

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

    SCITON, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 755 nm Alexandrite system is designed for use in: The ClearScan ALX 755nm Alexandrite laser system with its accessories is indicated for stable long-term, or permanent hair reduction 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. Q-Switched 755 nm Alexandrite Indications for Use: The JOULE Q-Switched 755 nm Alex Multi-Platform Systems with accessories are indicated for the following uses: Pigmented Lesions Tattoos The 1064 nm Nd:YAG Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to, telangiectasias and rosacea. Removal of unwanted hair (for stable, long term or permanent hair reduction) through selective targeting of melanin in hair follicles and for the treatment of Pseudofolliculitis Barbae (PFB). Treatment of facial wrinkles. The JOULE 1064 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis. Q-Switched 1064/532 nm Nd: YAG Indications for Use: The JOULE Q-Switched 1064/532 nm Nd:YAG Multi-Platform Systems with accessories are indicated for the following uses; Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Specific Indications: 1064 nm wavelength Tattoo Removal (dark ink: blue and black) Nevus of Ota Removal or lightening of hair with or without adjuvant preparation Skin Resurfacing for Acne Scars and Wrinkles Benign Cutaneous Lesions, such as, but not limited to: striae and scars Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. 532 nm wavelength Tattoo Removal (light ink: yellow, red, light blue, green) Vascular Lesions including but not limited to: port wine stains/birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi Epidermal Pigmented Lesions including but not limited to: Cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus Other Pigmented Cutaneous Lesions including verrucae, skin tags, keratoses and plaques Skin Resurfacing for Acne Scars and Wrinkles Benign Cutaneous Lesions, such as, but not limited to: striae and scars Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The 1319 nm Nd:YAG Indications for Use: Treatment of fine lines and wrinkles. Treatment of atrophic acne scars. Treatment of mild to moderate inflammatory acne vulgaris. The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis. The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity. 1470 nm Indications for Use: The JOULE 1470 nm Multi-Platform Systems and delivery accessories are intended for delivery of laser light to soft tissue for use in incision, excision, vaporization, ablation, hemostasis or coaqulation of soft tissue. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The JOULE 1470 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. 1550 nm Indications for Use: The JOULE 1550 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. 2940 nm Indications for Use: The JOULE 2940 nm Multi-Platform Systems with delivery accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Aesthetic Surgery: Skin resurfacing and treatment of wrinkles. Dermatology & Plastic Surgery: Indications include epidermal nevi, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, and decubitis ulcers. It is also used for laser assisted site preparation for hair transplantation. The JOULE 2940 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing, and ablation and coagulation of soft tissue. BBL (300-1400nm) Indications for Use: The Joule Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dematology. It is intended for use for: Mild to moderate inflammatory and pustular inflammatory acne vulgaris. (420nm BP filter, 515nm LP filter, 560 LP filter) The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm LP filter, 560nm LP filter) The treatment of cutaneous lesions including warts, scars and striae; (515nm LP filter, 560nm LP filter) The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter) The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction (590nm LP filter, 640nm LP filter, 695 LP filter) 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 muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800 nm LP filter) The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling); Reduce discomfort during and/or associated with light or laser treatment: Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation; Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).
    Device Description
    The JOULE Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.
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    K Number
    K081352
    Device Name
    PROFILE MULTI-PLATFORM SYSTEM
    Manufacturer
    SCITON, INC.
    Date Cleared
    2008-10-23

    (162 days)

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

    SCITON, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    755 nm Indications for Use: The 755 nm Profile Multi-Platform System with its accessories is indicated for stable long-term, or permanent hair reduction 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. 1320 nm Indications for Use: The 1320nm Profile Multi-Platform System with its accessories is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Profile 1320nm laser is further indicated for laser assisted lipolysis. 2940 nm Indications for Use: The 2940 nm Profile Multi-Platform System with Profractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
    Device Description
    The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.
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