THERMAGE CRYOGEN CANISTER

Primary DI

00850608002131

Basic UDI-DI Code

081699502B0001W4

Reference

TC-1-4

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Solta Medical, Inc.

The Thermage CPT System utilizes disposable, non-sterile cryogen canisters containing either (HCF-134A or HFO-1234ZE) for indirect cooling. HFO-1234ZE is permitted for use in geographical regions where environmental regulations limit high Global Warming Potential (GWP) refrigerant gases.Indirect cooling is achieved by cooling the non-patient contacting side of the treatment tip. Cryogen does not come into contact with the patient's skin at any time during treatment. Cryogen is delivered before, during, and after energy delivery to protect the epidermis from the heat generated in the underlying dermis

The Basic UDI-DI associated with this device has 10 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).