Skin Sheek

Warning LetterClosed

Meredith Dodini Hult President Skin Sheek 4431 W. Spruce Court Highland , UT 84003 United States service@skinsheek.com meredithhult@gmail.comIssued Jan 28, 2022Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: Skin Sheek
Location: Meredith Dodini Hult President Skin Sheek 4431 W. Spruce Court Highland , UT 84003 United States service@skinsheek.com meredithhult@gmail.com
FEI Number: N/A
Country: United States
Issue Date: January 28, 2022
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Closed
Closeout Letter: March 14, 2023

Summary

Skin Sheek marketed four medical devices (CLEAR, ERASE, LIFT, and SILK) without required FDA premarket approval or clearance, violating the Federal Food, Drug, and Cosmetic Act. The CLEAR device was found to be adulterated because the company lacked either an approved Premarket Approval (PMA) application or an Investigational Device Exemption (IDE), and was also misbranded for failing to submit the required premarket notification (510(k)). The FDA determined that Skin Sheek was marketing the CLEAR for unapproved intended uses beyond the scope of legally classified needle-type epilators, including treatment of telangiectasia and clogged pores, which exceeded the device's authorized indications.