Search Results

This device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.

COOLSKIN is a 14" by 16" by 2 ¾ ft, 66 lb thermo-cooling mobile device that applies controlled cooling in the range of 3 degrees F to 50 degrees F (-16 degrees C to 10 degrees C) at skin surface in order to decrease skin temperature via a probe which is in direct contact with the skin surface. The device operates by semiconductor using Peltier principle. While the proximal side (towards the skin surface) gets cold, the distal side gets hot. The hot side is cooled by a water cooling system, which runs to the probe tip via a water circulating tube, and cools it. The warm/hot water is channeled away to the main unit where it is cooled via a fan. The probe is available in small and large versions.

This document does not contain the information required to fulfill the request. The provided text is a 510(k) summary for a skin cooling device (COOLSKIN), which primarily focuses on establishing substantial equivalence to a predicate device. It does not include details about acceptance criteria, a specific study proving those criteria were met, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The document states:

• "COOLSKIN is safe and effective as the predicate device cited above."
• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".

This indicates the device's clearance was based on demonstrating equivalence, not necessarily on a detailed performance study with defined acceptance criteria as described in the prompt's requirements.

Ask a specific question about this device