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510(k) Data Aggregation

    K Number
    K240831
    Device Name
    MultiCut Solo
    Manufacturer
    Asclepion Laser Technologies GmbH
    Date Cleared
    2024-11-06

    (225 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Asclepion Laser Technologies GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surqical procedures in urology.
    Device Description
    MultiCut Solo consists of a special endoscopic handpiece in which a blade is inserted which mechanically shreds the tissue. The blade is driven by a dc motor, which is integrated in the handpiece. The motor itself is driven by a motor driver PCB. The blade can rotate at different speeds and thereby change the direction of rotation periodically (so called oscillation). The morcellator handpiece is also connected by an aspiration tube set to a peristaltic aspiration pump. By this pump the crushed tissue can be transported through a hollow channel in the handpiece to a waste container. The device is available with either sterile single use blades and non-sterile reusable blades.
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    K Number
    K241600
    Device Name
    Dermablate
    Manufacturer
    Asclepion Laser Technologies GmbH
    Date Cleared
    2024-07-03

    (29 days)

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

    Asclepion Laser Technologies GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermablate System with its accessories is indicated for coagulation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes). Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
    Device Description
    Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, detachable handpieces, and a footswitch. The device can be operated with micro beam and non-micro beam handpieces. The system incorporates a suction unit for the safe removal of laser plume. The laser is fired with a foot-operated switch (footswitch).
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    K Number
    K240816
    Device Name
    MeDioStar
    Manufacturer
    Asclepion Laser Technologies GmbH
    Date Cleared
    2024-04-23

    (29 days)

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

    Asclepion Laser Technologies GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MeDioStar laser system is intended for surgical, aesthetic applications in the medical specialties of general and plastic surgery and dermatology. The MeDioStar laser system is intended for the treatment of benign vascular lesions. The MeDioStar laser system is intended for the treatment of benign pigmented lesions. The MeDioStar laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months ..
    Device Description
    The modified MeDioStar is a pulsed diode laser emitting a wavelength of 755 - 1060 nm that is operated with a handpiece in contact with the skin. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. There are several handpieces, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.
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    K Number
    K231876
    Device Name
    MultiPulse HoPLUS
    Manufacturer
    Asclepion Laser Technologies GmbH
    Date Cleared
    2024-02-22

    (241 days)

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

    Asclepion Laser Technologies GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laser Device: The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, Urology Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BHP) Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enucleation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia Lithotripsy and Percutaneous Urinary Lithotripsy Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate Dehydrate stones Endoscopic fragmentation of kidney calculi Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitis Hemorrhoids Cholecystectomy Benign and Malignant Neoplasma Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions Arthroscopy Arthroscopy / Orthopedic surgery (excision, ablation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including: Ligament and tendon Release Contouring and sculpting of articular surfaces Capsulectomy in the knee Chondreoplasty in the knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retineacular release Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Forminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy Pulmonary Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue) Gynecology Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue ENT Endoscopic endonasal surgery (incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal / sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal sinustomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Dermatology and Plastic Surgery Incision, excision, resection, ablation, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas General Surgery Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy Morcellator: The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.
    Device Description
    Laser Device: The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, Urology Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BHP) Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enucleation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia Lithotripsy and Percutaneous Urinary Lithotripsy Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate Dehydrate stones Endoscopic fragmentation of kidney calculi Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitis Hemorrhoids Cholecystectomy Benign and Malignant Neoplasma Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions Arthroscopy Arthroscopy / Orthopedic surgery (excision, ablation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including: Ligament and tendon Release Contouring and sculpting of articular surfaces Capsulectomy in the knee Chondreoplasty in the knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retineacular release Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Forminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy Pulmonary Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue) Gynecology Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue ENT Endoscopic endonasal surgery (incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal / sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal sinustomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Dermatology and Plastic Surgery Incision, excision, resection, ablation, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas General Surgery Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy Morcellator: The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.
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    K Number
    K213597
    Device Name
    MultiCut Solo
    Manufacturer
    Asclepion Laser Technologies GmbH
    Date Cleared
    2023-01-18

    (432 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Asclepion Laser Technologies GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.
    Device Description
    The MultiCut Solo consists of a special endoscopic handpiece in which a blade is inserted which mechanically shreds the tissue. The blade is driven by a dc motor, which is integrated in the handpiece. The motor itself is driven by a motor driver PCB. The blade can rotate at different speeds and thereby change the direction of rotation periodically (so called oscillation). The morcellator handpiece is also connected by an aspiration tube set to a peristaltic aspiration pump. By this pump the crushed tissue can be transported through a hollow channel in the handpiece to a waste container.
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    K Number
    K213889
    Device Name
    PicoStar
    Manufacturer
    Asclepion Laser Technologies GmbH
    Date Cleared
    2022-04-22

    (130 days)

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

    Asclepion Laser Technologies GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PicoStar laser system is indicated for the following at the specified wavelength: 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-III. 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-V) to treat the following tattoo colors: black, brown, green, blue and purple. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV. Only with microspot handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. Only with microspot handpiece. indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
    Device Description
    PicoStar is a solid state laser capable of delivering energy at wavelengths of 1064 nm, or 532 nm at short durations of max 400 picoseconds (ps) and repetition rates up to 10 Hz. The device system is composed of a system console, an articulated arm, and attached delivery handpieces (full spot or microspot). The laser output at each wavelength is delivered to the skin through an articulated arm delivery system terminated by a handpiece. The PicoStar is controlled via a touch screen display housed in the front of the device. The control panel enables the user to select the desired energy density level and repetition rate. Emission is triggered by means of a footswitch.
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    K Number
    K210634
    Device Name
    MCL 31 Dermablate System
    Manufacturer
    Asclepion Laser Technologies GmbH
    Date Cleared
    2022-04-13

    (406 days)

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

    Asclepion Laser Technologies GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MCL 31 Dermablate System with its accessories is indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes). The MCL 31 Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
    Device Description
    The MCL 31 Dermablate System is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, detachable handpieces, and a footswitch. The MCL 31 Dermablate System can be operated with micro beam and non-micro beam handpieces. The system incorporates a suction unit for the safe removal of laser plume. The laser is fired with a foot-operated switch (footswitch).
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    K Number
    K192483
    Device Name
    MeDioStar
    Manufacturer
    ASCLEPION LASER TECHNOLOGIES GMBH
    Date Cleared
    2020-03-13

    (185 days)

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

    ASCLEPION LASER TECHNOLOGIES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MeDioStar laser system is intended for surgical, aesthetic applications in the medical specialties of general and plastic surgery and in dermatology. The MeDioStar laser system is intended for the treatment of benign vascular lesions. The MeDioStar laser system is intended for the treatment of benign pigmented lesions. The MeDioStar laser system is intended for hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.
    Device Description
    The MeDioStar is a pulsed diode laser emitting a wavelength of 750 - 950 nm that is operated with a handpiece in contact with the skin. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. There are several handpieces, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.
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    K Number
    K161257
    Device Name
    MultiPulse HoPLUS
    Manufacturer
    ASCLEPION LASER TECHNOLOGIES GMBH
    Date Cleared
    2017-03-31

    (331 days)

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

    ASCLEPION LASER TECHNOLOGIES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
    Device Description
    The MultiPulse HoPLUS Laser system and its fiber optic delivery system is a laser Class IV, pulsed, solid state Holmium-YAG, which emits laser radiation with a wavelength of approximately 2100 nm with a pulse with between 150-1700 microseconds. The laser power up to 140 Watts is transmitted to the tissue through different optical fibers. The laser system consists of: Laser system including control panel (user interface) Foot switch A variety of application fibers and accessories
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    K Number
    K152153
    Device Name
    MicroSpot Handpiece
    Manufacturer
    ASCLEPION LASER TECHNOLOGIES GMBH
    Date Cleared
    2015-12-11

    (130 days)

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

    ASCLEPION LASER TECHNOLOGIES GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroSpot Handpiece is intended for Dermatological procedures and Skin resurfacing procedures.
    Device Description
    The MicroSpot Handpiece is a handpiece with microbeam output to be used with the previously cleared MCL 31 Dermablate (K150140). The MCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. The MCL 31 can be operated with a handpiece of larger spotsize or with a microbeam handpiece. The system incorporates a suction unit for the safe removal of laser plume.
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