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The Skin Clinic Freeze Point product is intended for the treatment of common warts, plantar warts, and skin tags by OTC consumers. Treat skin tags in adults age 22 years or older

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The Skin Clinic Nitro Clear Wart Remover is intended for the OTC treatment of common warts and plantar warts in adults and children 4 years of age and older.

The Skin Clinic Nitro Clear Wart Remover device utilizes extreme cold to facilitate the removal of common and plantar warts by freezing. Each device contains a container of cryogen gas in a plastic holder along with instructions for use. The Skin Clinic Nitro Clear Wart Remover device is for OTC use and utilizes Nitrous Oxide cryogen delivered from the cartridge into a tip which acts as a reservoir for the cryogen gas. The applicator tip is cooled to as low as -89°C. Depending on the location and size, the applicator is placed against the common wart or plantar wart between 10-40 seconds which freezes the targeted area. The frozen wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.

The CryoFreeze Wart and Skin Tag Remover is intended for use in the over-the-counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 years or older.

The CryoFreeze Wart and Skin Taq Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common, plantar warts, and skin tags. The device includes: - A pressurized aerosol canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane - Applicator swabs - Detailed instructions, including illustrated descriptions To use the device, the user must insert an applicator swab into the actuator, saturate the swab with cryogen, and apply the foam tip of the swab directly onto the lesion, holding it in place for 40 seconds. After removal, the frozen tissue will appear white and begin to thaw, typically taking 20-40 seconds. The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.

The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, intended for use in open. minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-Ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is also intended for use in the following indications: General Surgery - · Destruction of warts or lesions. - · Palliation of tumors of the oral cavity, rectum, and skin. - · Ablation of breast fibroadenomas. - Ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Urology · Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia. Gynecology - · Ablation of malignant neoplasia or benign dysplasia of the female genitalia. Oncology - · Ablation of cancerous or malignant tissue. - · Ablation of benign tumors. - · Palliative intervention. - Neurology - · Freezing of nerve tissue in pain management/cryoanalgesia. Dermatology · Ablation or freezing of skin cancers and other cutaneous disorders. Proctology - · Ablation of benign or malignant growths of the anus and rectum. - · Ablation of hemorrhoids. Thoracic Surgery - · Ablation of cancerous lesions.

The Co-Ablation System with Sterile Co-Ablation Probe is a device designed to freeze/ablate tissue. It utilizes phase change effect to generate extremely low temperature and high temperature to destroy lesion tissues with a combined working mode, to achieve better clinical efficacy, safety and efficiency. Main components: Co-Ablation System, Sterile Co-Ablation Probe. Accessory: Sterile Temperature Probe. The Co-Ablation System is a mobile medical equipment. The Co-Ablation System consists a host of Co-Ablation System including liquid nitrogen storage tank (referred to as cryotank), cryo-valve, warm working medium storage tank (referred to as warmtank), warm-valve, waste bottle,insulated pipe and control/display system, etc. The Co-Ablation System has model number with AI Epic S40U and AI Epic S20U. The Sterile Co-Ablation Probe is a single-use sterile product, consisting of a handle, quick release connector, probe tip and probe shaft. It must be used in conjunction with the Co-Ablation System. During treatment, the Sterile Co-Ablation Probe is inserted into the lesion to be ablated. The freezing channel is opened, and the freeze working medium (liquid nitrogen) rapidly flows to the probe and evaporates to absorb heat, rapidly freezing and destroying tissue near the probe tip. When the system is switched from the freeze mode to warm mode, high temperature steam passes to the tip of the Sterile Co-Ablation Probe, rapidly heating the tip portion of the Sterile Co-Ablation Probe so that the frozen tissue around the Sterile Co-Ablation Probe is quickly melted, and the Sterile Co-Ablation Probe is easily pulled out. The Sterile Co-Ablation Probe consists of right-angle and straight configurations with model number Elite, and comprises 20 specifications as listed below: | Model | Specifications | Structural Form | |-------|----------------|---------------------| | Elite | ACL17 | Straight shaped | | | ACS17 | | | | ACX17 | | | | ABL20 | Right-angled shaped | | | ABS20 | | | | ABX20 | | | | ADL26 | | | | RCL17 | | | | RCS17 | | | | RCX17 | | | | RBL20 | | | | RBS20 | | | | RBX20 | | | | RBL26 | | | | RBS26 | | | | RBX26 | | | | RAL26 | | | | RAS26 | | | | RAL30 | | | | RAS30 | | The Sterile Temperature Probe is designed for use with the Co-Ablation System to monitor temperatures in the surrounding tissue. The Sterile Temperature Probe with model number Ease, and comprises 4 specifications: TSS08, TSL08, TMS15 and TML15.

The Advanced Cryo Wart Remover is designed as an over-the-counter (OTC) self-care device indicated for adults and children from the age of four years and older for the treatment of common and plantar warts.

The Advanced Cryo Wart Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common and plantar warts. The device includes: - A 15 mL / 0.51 oz pressurized aerosol canister containing a freezing agent (1,1-Difluoroethane, Propane, and Isopentane). - A metal tip that applies the cryogen directly to the wart - Detailed instructions, including illustrated descriptions. To activate the product, the lay user must, while holding the device facing downward, press the side buttons firmly five times in a row. Apply the cold metal tip for 20 seconds on warts located on the hands, tops of feet, and toes. Apply for 40 seconds on plantar warts in areas with thicker or calloused skin. The device is non-sterile, reusable, and intended for home use by laypersons. No special training or sterilization is required for operation.

The Verruca-Freeze® H cryosurgical system is indicated for use in the treatment of the following skin lesions: - · Actinic Keratosis - · Genital Warts - · Lentigo - · Molluscum Contagiosum - · Seborrheic Keratosis - · Skin Tags - · Verruca Plantaris - · Verruca Vulgaris - · Verruca Plana

The Verruca-Freeze® H cryosurgical system is used for treatment of benign skin lesions. The device consists of: • Canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane • Polyurethane foam swabs • Detailed instructions including illustrated descriptions The main component of the device is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed after each use. The foam swabs allow the cryogen to be localized to a target lesion. The one- to two-minute procedure begins by spraying cryogen onto a foam swab, which is then placed directly onto held for 15-40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thaw time is 20-40 seconds. This treatment methodology is simple and has been an accepted by physicians for decades. It utilizes a standard cryogen composition profile to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation are occurring.

Compound W® Skin Tag Remover is intended for the OTC treatment of skin tags in adults age 22 years or older.

Compound W® Skin Tag Remover is a cryogenic device intended to remove acrochordons (skin tags) via epidermal cryotherapy, destroying target epidermal cells by using extremely cold temperatures. The device contains a non-replaceable, non-refillable aluminum canister holding the gases dimethyl ether and propane. Activation of the device ejects a dose of the gases into a disposable polyurethane foam applicator tip, resulting in freezing of the applicator to approximately -30°C. The cold applicator tip is placed on the skin tag, thus destroying the target tissue. Each Compound W® Skin Tag Remover device is supplied in a paperboard carton with eight disposable tips, plastic tweezers, adhesive "Tag Target" skin-protecting discs, and an Instructions-for-Use leaflet.

The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation PROBES.

The AtriCure cryolCE BOX (ACM) is an electro-mechanical cryogenic surgical system that delivers a Nitrous Oxide (№0) cryo-genic energy source to a PROBE to create lines of ablation through tissue. The ACM includes single use PROBES (not part of this submission), Component and Accessories. The ACM provides controlled lesion forming temperature that is below -40°C (-40°F). In addition to the Activation Button on the front panel of the ACM, an accessory Footswitch can also be used to activate and terminate the cryo ablation cycle. The ACM is designed to operate only with AtriCure's PROBES. Refer to the AtriCure's PROBE Instruction for Use for detailed use and description.

The Skin Clinic Freeze Point product is intended for the treatment of common and plantar warts by OTC consumers. May be used with children 4 years of age or older under adult supervision.

The Skin Clinic Freeze Point device utilizes extreme cold to facilitate the removal of warts and by freezing. Each kit contains a container of cryogen gas in a plastic holder and instructions for use. The device is for OTC use and utilizes difluoroethane cryogen delivered from the canister into a foam wrapped tip which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to as low as -50°C. The applicator is then placed against the wart for up to 40 seconds which freezes the targeted tissue. The frozen wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.

Pixie® Skin Tag is a cryogenic device for home use intended to treat skin tags in persons over the age of 21.

Pixie Skin Taq is a pen-like cryogenic device that utilizes pressurized nitrous oxide (NoO, liquefied) to destroy skin tag tissue. The N2O is released into a single-use, disposable applicator, cooling the applicator as the result of rapid evaporation. The cooled applicator is briefly contacted with the skin tag while the surrounding tissue is protected by a disposable thermally insulating adhesive bandage. Each Pixie Skin Tag device is supplied in a carton with instructions for use and replacement applicator tips and insulating adhesive bandages.