Address:1100 Conroy Place,Easton,PA,18040,US
Device Description : Histofreezer, Kit, U.S., 60MC2 + 10The Histofreezer Portable Cryosurgical System Histofreezer, Kit, U.S., 60MC2 + 10The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
Device Class :
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CryOmega is a disposable device intended for the surgical destruction of tar The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions of lesions that can be treated:• Actinic Keratosis• Genital Lesions• Lentigo• Molluscum Contagiosum• Seborrheic Keratoses• Skin Tags• Verruca Plana• Verruca Plantaris• Verruca VulgarisAngiomas• Acne (Cysts & Scars)• Scars (Keloids)• Angiomas• Spider Angiomas• Teleangiectases• Keratosis Pilaris (Milia)• Sebaceous HyperplasiaThe CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.
Device Class :
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : Histofreezer FLEX Kit 50SB Small Bud Kit. The Histofreezer FLEX is intended for Histofreezer FLEX Kit 50SB Small Bud Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.
Device Class : 2
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : Histofreezer FLEX Kit 50SC Small Cone Kit. The Histofreezer FLEX is intended fo Histofreezer FLEX Kit 50SC Small Cone Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.
Device Class : 2
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : Histofreezer FLEX Kit 50SM Small Mixed Kit. The Histofreezer FLEX is intended fo Histofreezer FLEX Kit 50SM Small Mixed Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.
Device Class : 2
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : Histofreezer FLEX Kit 80SM Small Mixed Kit. The Histofreezer FLEX is intended f Histofreezer FLEX Kit 80SM Small Mixed Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.
Device Class : 2
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes