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The Verruca-Freeze H Plus cryosurgical system is intended for use by trained medical professionals to treat the following benign skin lesions:

• Actinic Keratosis
• Genital Warts
• Lentigo
• Molluscum Contagiosum
• Seborrheic Keratosis
• Skin Tags
• Verruca Plantaris
• Verruca Vulgaris
• Verruca Plana

The main component of the Verruca-Freeze® H Plus cryosurgical system 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 of after each use. The foam swabs allow the cryogen to be localized to a target lesion.

The procedure begins by saturating a foam swab with cryogen and then placing it directly onto the lesion for 15–40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thawing. The typical thaw time is 20–40 seconds. This treatment methodology is simple and has been an accepted practice used by physicians for decades. It utilizes a cryogen formulation to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation occur. This submission includes a modification to the cryogen formulation. No other changes were made to the device design, intended use, or operating principle.

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