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PainFreeze II Medium Stream and Mist Spray are vapocoolants (skin refrigerants) intended for topical op skin. intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. PainFreeze II's skin refrigerant controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical (lancing boils, incisions, drainage of small abscesses, and sutures), and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).

The Subject Device consists of a chemical blend of 60% HFO-1233zd (Trans-1-chloro-3.3.3- trifluoropropene) and 40% HFO-1234ze (trans- 1.3.3.3-tetrafluoroprop-1- ene) that produces a cooling effect upon contact with the skin, intact mucous membranes, and minor open wounds. The product is delivered in the form of an aerosol in either a mist or stream spray. The device's delivery system controls the amount of chemical blend that is dispensed, the mist spray configuration produces very fine droplets that cools at the points of contact. The stream spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Upon contact with the skin, the product begins to evaporate immediately as it contacts the skin. The low evaporation rate of the product's chemical blend is what creates the coldness. The Subject Device is non- flammable and has a lower global warming potential than the predicate and provides equivalent performance. The Subject Device is topically sprayed onto the skin. It creates a cooling effect on the surface of the application site by the immediate evaporation of the product from the skin surface. With both product configurations, the evaporation creates the cold sensation. As the distance from the target surface is increased, the dispersion of the droplets in both the mist and stream is increased. Increasing the surface area of contact and decreasing the size of the droplets increases the evaporation rate. The increase in evaporation rate correlates to an increase in the cooling effect. The chemical blend is incorporated in pressurized canisters, which will be offered in two (2) volumes 35 and 115 ml. The canister consists of a high-pressure canister, valve, and actuator.

For the treatment of verruca (warts) including plantar warts, sehorrheic keratosis, achrochorodon, molluscum, contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chrondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granualpma.

The Subject Device is used in the practice of dermatology in the treatment of skin lessons using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a cryogen composition profile to freeze common skin lessons that is has a lower global warming potential then the predicate device and is safe and provide equivalent performance. The chemical composition is a blend of HFC-32 and HFO-1234ze. HFC-32, difluoromethane, is a colorless gas typically used as a refrigerant. HFO-1234ze, trans-1,3,3,3-tetrafluoroprop-1-ene, is a colorless gas and a new generation hydrofluoroolefin developed for its low global warming potential.

Mist Spray: CryoDose TA OTC is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries. Stream Spray: CryoDose TA OTC is used like ice for muscle spasm and for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.

Nuance Medical's CryoDose TAOTC (subject device) is an over-the-counter (OTC) device designed to deliver a standard mixture 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,2-Tetrafluoroethane), which is being offered in two delivery configurations, Mist Spray (Model No. 1815) and Stream Spray (Model No. 1821). This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device's delivery system controls the amount of the CryoDose TA TTC mixture that is dispensed, the Mist Spray configuration produces very fine droplets that create cooling at the points of contact. The Stream Spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Both configurations contain the same standard mixture thus there is not safety or effectiveness concerns between configuration. The skin is cooled through rapid evaporation of the non-medicated propellants.

Pain Freeze™ Mist Spray and Medium Stray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Pain Freeze™ controls pain associated with injections (venipuncture, IV starts, cosmetic procedures (such as lancing boils, incisions, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains. bruising, cuts and abrasions). Pain Freeze™ Medium Stream Spray is also intended for the management of myofascial pain, restricted motion and muscle tension.

Nuance Medical's Pain Freeze™ (subject device) is a prescription device designed to deliver a standard mixture 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane), which is being offered in two delivery configurations, Mist Spray (Model No. 2102) and Medium Stream Spray (Model No. 2101). This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device's delivery system controls the amount of the Pain Freeze™ mixture that is dispensed, the Mist Spray configuration produces very fine droplets that create cooling at the points of contact. The Medium Stream Spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Both configurations contain the same standard mixture thus there is not safety or effectiveness concerns between configuration. The skin is cooled through rapid evaporation of the non-medicated propellants.

The CryoDose H indications for use as follows: CryoDose H is indicated for use in the treatment of actinic keratosis, genital warts, lentigo, mulluscum contagiosum, sebortheic keratosis, skin tags, verruca vulgaris, and verruca plana.

The proposed device, CryoDose H, is used in the practice of dermatology in the treatment of benign skin lesions using a cryogen spray system. The device consists of an aerosol-filled canister and parts within the canister. The canister is sold within a kit with accessories including: Directions for Use, swabs, and packaging materials. The aerosol is sprayed onto a foam covered cotton swab that is then placed upon the benign lesion (e.g. wart) for 15-40 seconds.

1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

The Nuance Freeze Spray System is used in the practice of dermatology in the treatment of skin lesions using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a standard cryogen composition profile to freeze common skin lesions.