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# FDA Warns UK Face Mask Marketer
- URL: https://www.fdaweb.com/fda-warns-uk-face-mask-marketer/
- Published: 2021-08-26T12:00:00.000Z
- Updated: 2026-09-14T17:11:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150027

FDA has issued a [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/invisi-smart-technologies-uk-ltd-614512-08242021?ref=fdaweb.com) to Invisi Smart Technologies (United Kingdom) over its Invisi Smart Mask for sale in the U.S. without a cleared 510(k). FDA contacted the firm 10/2020 about submitting a premarket notification. As of 6/21, FDA says no submission has been received and the face masks are still being marketed. The letter requests that the firm immediately cease activities that result in the misbranding or adulteration of the marketed masks.