ISOLAZ CRYOGEN CANISTER

Primary DI

00816995020561

Basic UDI-DI Code

081699502B0008WJ

Reference

IS-TC-4

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Solta Medical, Inc.

The cryogen is packaged in cases of four canisters. Each canister contains 425 grams of either HFC-134a (IS-TC-4) or HFO-1234ze (IS-TC-4ze). A cap, which is provided in the Isolaz 2 Accessory Kit (refer to the Isolaz 2 IPL System Technical File for details and contents of the Isolaz 2 Accessory Kit) attaches to the threaded end of the canister. This allows the user to deliver aerosolized cryogen onto the treatment tip which cools the flash lamp, extending its useful lifespan. The cryogen can be used for multiple treatments and should be maintained per the instructions in the Isolaz 2 IPL System User Manual, P009317. See Figure 1-5 for a rendering of the cryogen canister.

The Basic UDI-DI associated with this device has 11 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).