Cryogen Canister

Primary DI

00850608002148

Basic UDI-DI Code

081699502B0001W4

Reference

TC-2-4

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Solta Medical, Inc.

The Thermage FLX System utilizes disposable, non-sterile cryogen (1234ze, chemical name: trans-1,3,3,3-Tetrafluoroprop-1-ene) canisters for indirect cooling. Indirect cooling is achieved by cooling the non-patient contacting side of the treatment tip. Cryogen is delivered before, during, and after energy delivery to protect the epidermis from the heat generated in the underlying dermis. The pressure and delivery of cryogen is controlled such that when the coolant canister is low, a message is displayed on the computer screen for notification. The cryogen does not come in contact with the patient’s skin at any time during treatment.

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).