Description of Device:

The LM1000 is a CO2 cryosurgery system intended for the removal of skin tags,  utilizing carbon dioxide (CO2) as the cryogen. It operates by rapidly cooling a cryoprobe to temperatures between -45°C and -78°C. Upon activation, the CO2 gas expands and sublimates within the probe, absorbing heat and quickly lowering the probe tip temperature. The frozen probe is applied directly to the skin tag, causing intracellular and vascular freezing, leading to cell death. The treated tissue subsequently detaches naturally through the body's healing process.

The system features nine adjustable freeze intensity levels, selected via control buttons. An LCD screen displays the current battery status and selected intensity level. Two types of cryoprobes are included: a reusable probe for treating larger skin tags and a disposable single-use probe for smaller lesions. The device consists of a main unit with an integrated rechargeable battery, cryoprobes, and a charging cable.

Cryogen flow is regulated based on the selected intensity level, providing consistent and controlled cooling for tailored treatment of different skin tag sizes and thicknesses.

Intended Use:

The LM 1000 is intended for the OTC treatment of skin tags in adults age 22 years or older.

510(k) Number: K854767

Device Name: LM 1000

Manufacturer: COOPERSURGICAL, INC.