Description of the Subject Device:
The WA1000 is an over-the-counter(OTC) cryotherapy device designed for the treatment of common,plantar warts, and skin tags. The device includes:
• A pen-like cryogenic device
• A single-use, disposable applicator
• Detailed instructions, including illustrated descriptions
The WA1000 is a pen-like cryogenic device that utilizes pressurized nitrous oxide (N₂O, 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, the frozen tissue will appear white and begin to thaw. The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.
Indications for Use :
The WA1000 is intended for 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 or older.
Technological Characteristics
Device Name: WA1000
510(k) Number: K813024
Indications for Use: The WA1000 is intended for 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 or older.
Cryogen Material: Mixture of dimethyl ether, propane, and is obutane
Freeze Temperature: -55°C
Design:
- A pen-like cryogenic device
- Foam-tipped applicators
Mechanism of Action: Extreme cold destroys the target tissue
Treatment Procedure: Cryogen is dispensed into foam applicator which is then applied to the lesion for a specified number of seconds.
Storage and Safety Conditions:
-Keep away from fire or flame
-Do not smoke while using the product
-Do not puncture or incinerate canister
-Do not expose to heat or store at temperatures above 120°F.
-Store at room temperature away from heat
Disposal: Entire unit is disposable after emptied of cryogen
Defined Operators: OTC for consumer use