Search Filters

Search Results

Found 18 results

510(k) Data Aggregation

    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.
    Ask a Question
    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.
    Ask a Question
    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.
    Ask a Question
    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.
    Ask a Question
    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.
    Ask a Question
    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.
    Ask a Question
    K Number
    K070388
    Device Name
    PROFILE MULTI-PLATFORM SYSTEM
    Manufacturer
    SCITON, INC.
    Date Cleared
    2007-05-02

    (82 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
    1064 nm Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to-telangiectasia and rosacea. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles. Incision/excision and cutting, vaporization, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis. 1320 nm Indications for Use: It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris. Profile Multi-Platform System 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. 2940 nm Indications for Use; Skin resurfacing and treatment of wrinkles. Pulsed Light (300-1400 nm) Indications for Use: The Profile 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 dermatology. It is intended for use for: The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (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, 695nm LP filter) Treatment of facial wrinkles, treatment of fine lines and wrinkles; and (590nm LP filter, 640nm LP filter, 695nm LP filter, 800nm 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. (800nm LP filter)
    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.
    Ask a Question
    K Number
    K060033
    Device Name
    PROFILE MULTI-PLATFORM SYSTEM
    Manufacturer
    SCITON, INC.
    Date Cleared
    2006-02-28

    (54 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
    1064 nm Indications for Use: The Profile Multi-Platform Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, 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, venus lake, leg veins and spider 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. Additionally, the lasers are indicated for 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 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 targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles. The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments. Surgical Applications: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology. 1320 nm Indications for Use; The Profile Multi-Platform Systems and Accessories are intended for use in general surgery and dematology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris. Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of saphenous veins associated with varicose veins and varicosities. Profile 2000 nm Indications for Use: The Profile Multi-Platform Systems and Accessories are indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications: Dermatology and Plastic Surgery Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasias [facial, leg] and rosacea), corns, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization, Gastroenterological/Gastrointestinal Surgery Open and endoscopic gastroenterologic surgery of soft tissue(for incision, excision, resection, ablation, vaporization, coagulation and hernostasis) including; cholecystectorny, lysis of adhesions, appendectorny, biopsy, pylorostenotorny, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, uicers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding furnors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Oster-Weber-Rendu disease. General Surgery General surgery of soft tissues, including; skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, turnors and lesions, and tissue ablations; removal of benign and malignant lesions; mastectorny, hepatectorny, pancreatectorny, splenectorny, thyroidectorny, parathyroidectorny, herniorthaphy, tonsillectorny, lymphadenectorny, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectorny, pylorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectomy. Genitourinary Surgery/Urology Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors, superficial urinary bladder tumors, invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions. Endoscopic transurethral incision of prostate, ablation of benign prostatic hypertrophy, transurethral incision of prostate, laser resection of the prostate, laser enuculeation of the prostate, laser ablation of the prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy. Gynecological Surgery Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, including condyloma acuminate, intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septurn by incision, excision, ablation and or vessel coagulation, soft tissue excision procedures such as excisional conization of the cervix. Lithotripsy and Percutaneous Urinary Lithotripsy Lithotripsy and percutaneous urinary lithotripsy, including: fragmentation of urinary calculi, fragmentation of calculi in the ureter and ureteropelvic junction, fragmentation of kidney calculi, fragmentation of urethral calculi and treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed. Lumbar Discectorny Lumbar discectorny in soft, cartilaginous and bony tissue, including: vaporization of the L.4-5 and L.5-S1 lumbar discs of the vertebral spine; open, percutaneous and endoscopic spine procedures; foraminotomy. Orthopedic Surgery and Arthroscopy Orthopedic surgery in soft and catiliaginous tissue in small and large joints, including. knee meniscectorny, knee synovectorny, chondrornalacia and tears, loose body debridement, lateral retinacular release, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, loose body debridement, capsulectorny in the knee, chondroplasty in the knee, chondromalacia ablation, ablation of soft and cartilaginous tissue in minimal invasive spinal surgery including percutaneous laser disc decompression/ discectorny, foraminoplasty, ablation and coaqulation of soft vascular and non-vascular tissue in minimally invasive spinal surgery. Otorhinolaryrigological (ENT) Surgery Otorhinolaryrigological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue. including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectorny), dacı yocystorhinostomy (DCR), ethmoidectorny, polypectorny, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty, lesions or turnors of the oral, nasal, glossal, pharyngeal, tonsillectomy, adenoidectorny, adenoidectorny. Thoracic and Pulmonary Surgery Open and endoscopic thoracic and pulmonary surgery (incision, resection, ablation. vaporization, coagulation and hernostasis) of soft tissue, including laryngeal lesions, airway obstructions including carcinoma, polyps and granulomas, palliation of obstructing carcinomas of the tracheobroncial tree. 2940 nm Indications for Use: The Profile Multi-Platform Systems and Accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures. Aesthetic Surgery Skin resurfacing and treatment of wrinkles. Dental Application of Er: YAG It is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. Hard Tissue Indications of Er. YAG Laser Energy: Caries removal, cavity preparation, enamel etching, enameloplasty, excavation of pits and fissures for placement of sealant. Bone Indications of ETYAG Laser Energy. Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue, apicoectorny, osseous crown lengthening, culting bone to prepare a window access to the apex of the root, osseoplasty, osteotomy. Soft Tissue and Periodontal Indications of Er.YAG Laser Energy. Excisional and incisional biopsies, exposure of unerrupted teeth, incision and drainage of abscesses, gingival incision and excision, gingivoplasties, gingivectomies, gingivectorny in case gingwal mondow of the gingival or excision of hyperplasias, gingival troughing for or nyperplasias of the girls of the start recovery, frenectomies and frenotomies, fibromatosis, benign and malignant lesion removal, operculectorny, oral papillectornies, reduction of gingival hypertrophy, soft tissue crown lengthening, papilletin surgery (flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papilomas, fibrormatoses, benign growths), vestibuloplasty, sucular debridement Endodontal Applications of Er.YAG Laser Energy: Tooth preparation to obtain access to root canal, pulpotomy, pulpotomy as an adjunct to root canal therapy, pulp extirpation, root canal debridement and cleaning, root canal preparation including enlargement. Dermatology & Plastic Surgery Indications include, epidermal nevi, telangietasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers. It is also used for laser assisted site preparation for hair transplantation. Gastroenterology Gastroenterologic surgery of soft tissue, including: cholecystectorny, lysis of adhesions, appendectorny, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, nonbleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding turnors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease. General Surgery The Er: YAG is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation. Genitounnary/Urology Genitounnary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder turnors; invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions. Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy. Gynocology Indications include cervical intracpithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. Ophthalmology Optimalitions include soft tissue surrounding the eye and orbit and anterior capsulotomy. Oral/Maxillofacial Indications include oral/dental procedures for incision, excision, ablation, vaporization mulations more of soft tissue during gingivoplasties, gingivectornies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotorny, Otorhinolaryrigological (ENT) Surgery Otominolaryngological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate including. Chaosinus ourgery, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectorny, polypectorny, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty. Podiatry Indications include warts, plantar verruae, large mosaic verrucae and matrixectorny. Pulmonary Surgery Open and endoscopic pulmonary surgery. Thoracic Surgery Intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery. Pulsed Light (300-1400 nm) Indications for Use: The Profile 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 dermatology. It is intended for use for. - · The treatment of tattoos; - (560nm LP filter, 590nm LP filter) - · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP fifter, 560nm LP fifter) - · 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, The treathern of beliginical and leg telangiectasias, rosacea, erytherna of rosacea, angiomas and spider angiomas, poikilodema of Civatte, leg veins and venous malformations; (580nm LP filter, 590nm LP filter) - · Treatment of psociasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, (350nm BP filter) - · The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and - (590nm LP filter, 640nm LP filter, 695 LP filter) - · Mild to moderate inflammatory and pustular inflammatory acne vulgaris, (420nm BP filter, 515nm LP filter, 560 LP filter) The integral thermo-electric cooler is indicated for use in cooling the epidemis at the r the integral them of 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: - · Ninimize 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 Allow the use of mgner light of the treatment of vascular or pigmented lesions); and - as for hair removal and the a suarront of laser treatments (such as for hair removals and the treatment of vascular or pigmented lesions).
    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.
    Ask a Question
    K Number
    K040005
    Device Name
    PROFILE 2000/3000 LASER SYSTEM
    Manufacturer
    SCITON, INC.
    Date Cleared
    2004-03-29

    (87 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 Profile 2000 Laser System, and Delivery Devices and Accessories, is indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications: Dermatology and Plastic Surgery, Gastroenterological/Gastrointestinal Surgery, General Surgery, Genitourinary Surgery/Urology, Gynecological Surgery, Lithotripsy and Percutaneous Urinary Lithotripsy, Lumbar Discectomy, Orthopedic Surgery, Otorhinolaryrigological (ENT) Surgery, Pulmonary Surgery. The Profile 3000 Laser System, and Delivery Devices and Accessories, is indicated for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Aesthetic Surgery, Dermatology & Plastic Surgery, Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial, Otorhinolaryrigological (ENT) Surgery, Podiatry, Pulmonary Surgery, Thoracic Surgery.
    Device Description
    The Profile 2000 and Profile 3000 emits laser energy with wavelength of 2.01 µm and 2.94 µm respectively. The laser consists of a system console, internal computer, control panel and display, and a fiber optic delivery system and footswitch.
    Ask a Question
    K Number
    K032459
    Device Name
    PROFILE 1320 LASER SYSTEM
    Manufacturer
    SCITON, INC.
    Date Cleared
    2004-03-09

    (211 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 Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.
    Device Description
    Profile 1320 Laser System is an Nd:YAG laser producing emission at a wavelength of 1320 nm. It consists of a laser console, internal computer, control panel and displav. an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.
    Ask a Question

    Page 1 of 2