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# Gas-Controlled Tissue Expander is Class 2
- URL: https://www.fdaweb.com/gas-controlled-tissue-expander-is-class-2/
- Published: 2022-02-07T12:00:00.000Z
- Updated: 2026-09-14T17:31:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151093

*Federal Register* notice: FDA is classifying the carbon dioxide gas-controlled tissue expander into medical device Class 2 (special controls). The action was based on an AirXpanders de novo classification request for its AeroForm Tissue Expander System. The agency identified the device as being intended for temporary subcutaneous or submuscular implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. The device is made of an inflatable elastomer shell and is filled with carbon dioxide gas. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-02-04/pdf/2022-02357.pdf?ref=fdaweb.com).