Address:1100 Conroy Place,Easton,PA,18040,US
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 that can be treated: • Genital Lesions • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plantaris • Verruca Vulgaris • Verruca Plana • Actinic Keratosis • Lentigo • Acne (Cysts & Scars) • Scars (Keloids) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia. The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.
Device Class : 2
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 that can be treated: • Genital Lesions • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plantaris • Verruca Vulgaris • Verruca Plana • Actinic Keratosis • Lentigo • Acne (Cysts & Scars) • Scars (Keloids) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia. The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.
Device Class : 2
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CryoClear™ is a multi-use disposable device intended for the removal of targ The CryoClear™ is a multi-use disposable device intended for the removal of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated. • Lentigo (Age Spots)• Skin Tags• Actinic Keratosis (Sun Spots)• Acne (Cysts & Scars)• Angiomas• Spider Angiomas• Teleangiectases• Keratosis Pilaris (Milia)• Sebaceous Hyperplasia
Device Class :
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CryoClear™ is a multi-use disposable device intended for the removal of targ The CryoClear™ is a multi-use disposable device intended for the removal of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated. • Lentigo (Age Spots)• Skin Tags• Actinic Keratosis (Sun Spots)• Acne (Cysts & Scars)• Angiomas• Spider Angiomas• Teleangiectases• Keratosis Pilaris (Milia)• Sebaceous Hyperplasia
Device Class :
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CryoLab® Medical device uses CryoConcepts’ design and technology to deliver The CryoLab® Medical device uses CryoConcepts’ design and technology to deliver a spray of either Nitrous Oxide or Carbon Dioxide gas respectively to treat topical cutaneous lesions. The intended use for the CryoLab®, for both gases, is the surgical destruction of target tissue by extreme cold temperatures. Specifically, example lesions the device is intended to treat, based upon the literature, include molluscum contagiosum, skin tags, actinic keratosis, lentigo, verruca plana, verruca vulgaris, verruca plantaris, genital lesions, and seborrheic keratosis.
Device Class : 2
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CryoLab® Aesthetic device uses CryoConcepts’ design and technology to delive The CryoLab® Aesthetic device uses CryoConcepts’ design and technology to deliver a spray of Carbon Dioxide gas to treat topical cutaneous lesions. The intended use for the CryoLab® Aesthetics, is the surgical destruction of target tissue by extreme cold temperatures. Specifically, example lesions the device is intended to treat, based upon the literature, include skin tags, actinic keratosis, and seborrheic keratosis.
Device Class : 2
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : Histofreezer, Kit, U.S., 40T1CThe Histofreezer Portable Cryosurgical System is u Histofreezer, Kit, U.S., 40T1CThe 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 : 2
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : Histofreezer, Kit U.S, 36F1CThe Histofreezer Portable Cryosurgical System is use Histofreezer, Kit U.S, 36F1CThe 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 : 2
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : Histofreezer, Kit, U.S., 36M1CThe Histofreezer Portable Cryosurgical System is u Histofreezer, Kit, U.S., 36M1CThe 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 : 2
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes
Device Description : Histofreezer, Kit, U.S., 5M1CThe Histofreezer Portable Cryosurgical System is us Histofreezer, Kit, U.S., 5M1CThe 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 : 2
Duns Number: 038024868
Premarket Exempt : No
Prescription Use : Yes