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# Marci Beauty Selling Unapproved Light Therapy Devices: FDA
- URL: https://www.fdaweb.com/marci-beauty-selling-unapproved-light-therapy-devices-fda/
- Published: 2021-10-05T12:00:00.000Z
- Updated: 2026-09-14T17:17:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150293

FDA says it has learned that Marci Beauty, Spring Valley, NV, is selling seven light therapy devices without marketing clearance or approval. A just-released 2/2 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/marci-beauty-llc-612041-02022021?ref=fdaweb.com) says the products are legally regulated as medical devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The letter says the firm’s devices are adulterated because Marci does not have an approved PMA or IDE in effect for each device as described and marketed. The devices also are misbranded, FDA says, because Marci did not advise FDA of its intent to introduce them into commercial distribution.

In the letter, FDA asks that Marci cease any activities that result in the misbranding or adulteration of the listed devices, such as the commercial distribution of the devices for the indicated uses. The firm was told to take prompt action to correct the violations and respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.